STOCKS TELEGRAPH

Author: ST Staff

  • Why Lannett Company Inc. (LCI) stock rallied on Wednesday?

    Why Lannett Company Inc. (LCI) stock rallied on Wednesday?

    Lannett Company Inc. (LCI) stock surged 14.76% in the after-hours trading on Wednesday, June 16, 2021, and close the day at $5.52 per share. Earlier in the morning session, LCI shares gained0.63% to close Wednesday’s morning session at $4.81 per share. LCI shares have fallen 37.29% over the last 12 months, and they have moved down 8.21% in the past week. Over the past three months, the stock has lost 26.45%, while over the past six months, it has shed 27.12%.

    Let’s discuss its recent news and developments

    FDA accepted ANDA, Of the Generic Advair Diskus Filing

    On June 1, 2021, the U.S. Food and Drug Administration (FDA) accepted the Abbreviated New Drug Application (ANDA) for Fluticasone Propionate and Salmeterol inhalation powder (100/50 mcg, 250/50 mcg, and 500/50 mcg), which was submitted by Lannett on behalf of its strategic alliance partner, Respirent Pharmaceuticals Co. Ltd. The FDA assigned a Generic Drug User Fee Act of 2017 (GDUFA II) goal date for this priority original ANDA of January 31, 2022.

    Recent financial results announcement

    On May 5, 2021, Lannett Company, Inc reported its financial results for its fiscal 2021 third quarter ended March 31, 2021.

    Q3 2021 financial highlights

    • Lannett Company reported net sales of 4 million for Q3 2021compared with $144.4 million for the third quarter of fiscal 2020.
    • In Q3 2021, gross profit was $26.5 million compared to $41.7 million in Q3 2020.
    • Total operating expenses were $23.6 million in Q3 2021 compared with $43.8 million inQ3 2020.
    • Net loss was $7.1 million, or $0.18per share in Q3 2021, compared with $16.6 million, or $0.43 per share, for the third quarter of fiscal 2020.
    • In Q3 2021, adjusted net income was $1.0 million, or $0.02per diluted share, compared with $11.7 million, or $0.27 per diluted share, for the fiscal 2020 third quarter.
    • Adjusted EBITDA for the fiscal 2021 third quarter was $17.0 million.

    Closing of senior secured Notes & $190 million second lien senior secured loan facility

    On April 22, 2021, Lannett Company, Inc. closed the $350 million aggregate principal amount of 7.750% senior secured notes due 2026 in a private placement to qualified institutional buyers according to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”) and outside the United States to persons other than U.S. persons in reliance upon Regulation S under the Securities Act.

    The Company also closed on a $190 million second lien senior secured loan facility due 2026 and amended its asset-based revolving credit facility increasing the size to $45 million from $30 million and extending the maturity to 2026 from 2022.

    Conclusion

    Well, as of this writing there is no recent news or development which could be linked with LCI positive performance on Wednesday. We hope that LCI stock will continue its rally on Thursday as well.

  • Innate Pharma S.A. (IPHA) Stock Surges During After Hours Trading Ahead of Progress Update Meeting

    Innate Pharma S.A. (IPHA) stock prices were down by a marginal 1.87% as of the market closing on June 16th, 2021, bringing the price per share down to USD$3.9350. After-hours trading saw the stock rally by an impressive 10.55%, bringing it up to USD$4.40.

    Disclosure of New Data

    The company announced on June 10th, 2021 that it will present the most recent preclinical data from it’s next-gen, proprietary, multi-specific NK cell engager platform, ANKET. The presentation will be held at the Federation of Clinical Immunology Societies (FOCIS) meeting, showcasing Antibody-based NK cell Engager Therapeutics.

    FOCIS Presentation

    The presentation will see IPHA share new data from its tetra-specific ANKET molecule, which is the first NK cell engager technology to engage both NKp46 and CD16, the former of which is a tumor antigen and the latter a cytokine (IL-2 variant) in a single molecule. This newest development makes use of the advantages of harnessing NK cell effector functions against cells affected by cancer. It also facilitates the provision of the proliferation and activation The data set generated is founded on the company’s existing tri-specific NK cell engager technology. This technology has a proven track record of potent NK cell activation, cytotoxicity, and efficient management of tumor growth in preclinical models.

    Scope of ANKET

    Preclinical studies demonstrated the ability of in vitro tetra-specific ANKET to induce human NK cell proliferation, cytokine production, and cytolytic activity against cancer cells expressing the targeted antigen. Tetra-specific ANKET was also reported to have demonstrated in vivo anti-tumor efficacy in several tumor models, which allows for the regression of exiting tumors. Control of metastasis is also facilitated, with its associations with increased NK cell infiltration, and cytokine and chemokine production at the tumor site. The treatment also exhibited the pharmacodynamic effect, low systemic cytokine release, and a manageable safety profile in non-human primates.

    IPH6101

    The company’s leading ANKET asset is IPH6101, which has exhibited anti-tumor activity in preclinical models, including, but not limited to, facilitating pharmacokinetic pharmacodynamic and safety data in preliminary non-human primate studies. January 2021 saw the progression of the program into IND-enabling studies, with a recently announced research collaboration facilitating a second research program.

    Future Outlook for IPHA

    Armed with the development of their proprietary ANKET NK cell engager platform, IPHA is poised to continue its trajectory of success. The company is keen to continue working towards the commercialization and proliferation of their technology to usher in further gains. Current and potential investors are hopeful that management will continue to leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.

  • Why CureVac BV (CVAC) stock plummeted on Wednesday after an important announcement?

    Why CureVac BV (CVAC) stock plummeted on Wednesday after an important announcement?

    CureVac N.V. (CVAC) shares plunged 45.67% in the after-hours on Wednesday, June 16, 2021, and close the session at $51.50 per share. Earlier, in the morning session, CVAC’s stock lost 3.47% to close Wednesday’s session at $94.79 per share. CVAC shares have moved down by 10.34% in the past week. Over the past three months, the stock has gained 0.53%, while over the past six months, it has shed 21.70%.

    Let’s try to find out why CVAC stock lost significantly on Wednesday?

    Update on Phase 2b/3 Trial ofCOVID-19 VaccineCVnCoV

    On June 16, 2021, CureVac N.V. announced the results of the second interim analysis of its international pivotal Phase 2b/3 study in approximately 40,000 subjects (the HERALD study) of CureVac’s first-generation COVID-19 vaccine candidate, CVnCoV.

    CVnCoV demonstrated an interim vaccine efficacy of 47% against COVID-19 disease of any severity and did not meet prespecified statistical success criteria. The study is continuing to the final analysis and the totality of the data will be assessed for the most appropriate regulatory pathway.

    Earlier, on June 1, 2021, the company reported that the independent Data Safety Monitoring Board (DSMB) confirmed that the phase IIb/III study (HERALD) for CVnCoV has passed the first interim analysis in 59 adjudicated COVID-19 cases with no safety concerns.

    New appointment

    On June 2, 2021, CureVac N.V. appointed Klaus Edvardsen, MD, Ph.D., as Chief Development Officer. The appointment of Dr Edvardsen will take effect on August 1, 2021.

    Recent financial results announcement

    On May 26, 2021, CureVac N.V released its financial results for the first quarter of 2021.

    Q1 2021 financial highlights

    • CureVac reported revenue of €10.0 million for the first three months of 2021compared to revenue of €3.1 million for the same period in 2020.
    • The company suffered from an operating loss of €115.8 million for the first three months of 2021 compared to an operating loss of €23.2 million for the same period in 2020.
    • The cost of sales and other operating expenses were €26.3 million for Q1 2021 compared to €125.8 million in Q1 2020.
    • As of March 31, 2021, the company had cash and cash equivalents of€1,497 million compared to €1,323 millionas of December 31, 2020. 

    Conclusion

    The CVAC stock plummeted after the company announced that its Covid-19 vaccine shows 47% efficacy against Coronavirus variants. The CVAC stock can further go down on Thursday as well.

  • Here is why Satsuma Pharmaceuticals Inc (STSA) stock performed well on Wednesday?

    Here is why Satsuma Pharmaceuticals Inc (STSA) stock performed well on Wednesday?

    Satsuma Pharmaceuticals Inc. (STSA) shares surged 17.78% in the after-hours on Wednesday, June 16, 2021, and close the session at $5.83 per share. Earlier in the morning session, STSA shares gained 0.61% to close Wednesday’s morning session at $4.95 per share.

    STSA shares have fallen 82.69% over the last 12 months, and they have moved down 5.71% in the past week. Over the past three months, the stock has lost 24.54%, while over the past six months, it has added 2.27%.

    Let’s see what’s going on with STSA?

    Positive results on Phase 1 Trial of STS101 at Multiple Dose Strengths

    On June 16, 2021, Satsuma Pharmaceuticals, Inc. announced positive pharmacokinetic, tolerability, and safety results from a Phase 1 trial of STS101. The data demonstrated that all three dose strengths (5.2 mg and two higher dose strengths) administered with Satsuma’s improved second-generation nasal delivery device were well-tolerated and achieved the target pharmacokinetic profile.

    Recent financial results

    On May 11, 2021, Satsuma Pharmaceuticals, Inc released its financial results for the first quarter of 2021.

    Q1 2021 financial highlights

    • Satsuma Pharmaceuticals reported a net loss of $10.5 million, or $0.48 per common share for the first quarter of 2021compared to a net loss of $11.8 million, or $0.68 per common share, for the same period in 2020.
    • Research and development expenses were $7.2 million for Q1 2021, compared to $9.6 million for Q1 2020.
    • General and administrative expenses were $3.3 million for the first quarter of 2021, compared to $2.5 million for Q1 2020.
    • Satsuma Pharmaceuticals had $133.1 million of cash, cash equivalents, and marketable securities on March 31, 2021.

    Q4 and FY 2020 financial results announcement 

    On March 25, 2021, Satsuma Pharmaceuticals, Inc announced its financial results for the quarter and the full year ended December 31, 2020.

    Q4 2020 financial highlights 

    • Satsuma Pharmaceuticals reported a net loss of $12.5 million or $0.72per common share for Q4 2020 compared to a net loss of $10.8 million or $0.62per common share for Q4 2019.
    • Research and development expenses were $9.0 million for the fourth quarter of 2020 compared to $9.2 million for Q4 2019.
    • General and administrative expenses were $3.4 million for the fourth quarter of 2020 compared to $2.1 million for Q4 2019.

    FY 2020 financial highlights 

    • Satsuma Pharmaceuticals reported a net loss of $47.6 million or $2.73 per common share for FY 2020 compared to a net loss of $28.2 million or $4.80 per common share for FY 2019.
    • Research and development expenses were $36.3 million for the full year 2020compared to $24.2 million for FY 2019.
    • General and administrative expenses were $12.1 million for full-year 2020 compared to $4.7 million for FY 2019.
    • The Company had $68.2 million of cash, cash equivalents, and marketable securities on December 31, 2020.

    Conclusion

    The STSA stock performed well on Wednesday after the company announced the positive results which we have discussed above. STSA can continue its positive momentum in the remaining days of the current week.

  • Opthea Ltd. (OPT) Stock Skyrockets Seemingly Out of Nowhere; Could It Be the New Meme Stock?

    Opthea Ltd. (OPT) Stock Skyrockets Seemingly Out of Nowhere; Could It Be the New Meme Stock?

    Opthea Ltd. (OPT) stock prices were up by a massive 33.06% shortly after market trading commenced on June 16th, 2021, bringing the price per share up to USD$11.44 early on in the trading day.

    Contextualizing the Surge in Stock Price

    This massive overnight surge comes despite there being an absence of news coverage on any recent developments that would explain the fortuitous change in equity value. While meme stocks have been all the rage in the stock markets as of late, it seems unlikely that the movement in the price of company shares is due to the meme stock phenomenon. More likely is the case that the company has seen fundamental or market developments that have not yet reached the media.

    iPSP Waiver

    The end of March 2021 saw the company announce the receipt of an initial Pediatric Study Plan (iPSP) waiver from the U.S. Food and Drug Administration for OPT-302. The company’s leading product candidate is currently in Phase 3 clinical development for the treatment of neovascular (wet) age-related macular degeneration.

    Marketing Application for OPT-302

    With the intention of submitting a marketing application of the new treatment, the regulatory review process dictates that OPT provide the FDA with a proposed strategy for the investigation the new treatment in the pediatric population. Notably, the FDA has previously agreed to waive the iPSP requirement.

    Receipt of iPSP Waiver

    The company received such an official, agreed waiver from the FDA for OPT-302 across all subsets of the pediatric population. This includes the full pediatric age group under the age of 17 years. The waiver is for the treatment of wet AMD in conjunction with intravitreal anti-VEGF-A therapy. Due to the receipt of this iPSP waiver, OPT will not have to conduct further studies in the pediatric population.

    OPT-302 Trial

    The agreed iPSP will serve as a crucially significant regulatory milestone in the US, the completion of which will facilitate the submission of a marketing application for OPT-302 to the FDA. The company is committed to continuing the process to fulfill the regulatory requirements stemming from their focus on the pivotal Phase 3 clinical trial. These trials in adult patients are designed to support potential marketing approval of OPT-302 as a viable and effective treatment of wet AMD.

    Future Outlook for OPT

    Armed with the fortuitous surge in value of their equity, OPT is poised to capitalize on the opportunities presented to it. The company is keen to continue its trajectory of success and usher in more organic growth over the long-term. Current and potential investors are hopeful that the management will leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.

  • Orphazyme A/S (ORPH) Stock Skyrockets as Newest Target of Meme Stock Phenomenon

    Orphazyme A/S (ORPH) Stock Skyrockets as Newest Target of Meme Stock Phenomenon

    Orphazyme A/S (ORPH) stock prices skyrocketed by a monumental 71.24% shortly after market trading commenced on June 16th, 2021, bringing the price per share up to USD$17.21 early on in the trading day.

    Meme Stock Phenomenon

    The meme stock phenomenon continues to dominate the stock exchange, with a slew of stocks being targeted for a coordinated pump by the Reddit-driven retail investors. Underdogs with a high short interests find themselves fortuitously bolstered as the community of investors continues to target companies without a logical basis for their support. In the absence of recent news or any fundamental developments, companies sometimes on the brisk of collapse find themselves renewed by the sweeping meme stock craze.

    About ORPH

    OPRH is a late-stage biopharmaceutical company that specializes in the pioneering of a heat-shock protein response, which it uses to treat neurodegenerative orphan diseases. As such, OPRH aims to develop and commercialize novel therapeutics based on the amplification of heat-shock proteins. The company’s leading drug candidate is arimoclomol.

    Arimoclomol Development

    Arimoclomol is currently in clinical development targeted at four orphan diseases: Niemann-Pick disease Type C (NPC), Amyotrophic Lateral Sclerosis (ALS), Inclusion Body Myositis (IBM) and Gaucher disease. The company is based out of Denmark, with shares of its common stock listed on the Nasdaq as an American Depositary Receipt. With some operations based on the U.S, most of the company’s operations are focused in Europe.

    Future Outlook for ORPH

    Armed with the fortuitous surge in the value of their equity, ORPH is poised to capitalize on the opportunities presented to it. The company is keen to continue its trajectory of success and usher in more organic growth over the long-term. Current and potential investors are hopeful that the management will leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.

  • Greenland Technologies Holding Corp. (GTEC) Stock Undergoes Minor Volatility Despite Launch of EV Pre-Booking

    Greenland Technologies Holding Corp. (GTEC) Stock Undergoes Minor Volatility Despite Launch of EV Pre-Booking

    Greenland Technologies Holding Corp. (GTEC) stock prices were down by 4.62% shortly after market trading commenced on June 16th, 2021, bringing the price per share down to USD$9.07 early on in the trading day.

    Launch of EV Pre-Booking

    The company announced on June 15th, 2021 that it had launched an online EV pre-booking service for its new vehicles, the GEL-1800 1.8 ton Electric Loader and the GEX-8000 Electric Excavator. Delivery of the vehicles is expected to commence in August 2021, ahead of the previous forecasted schedule. The company website offers more information, as well as the facility to pre-book a vehicle with a USD$250 refundable deposit.

    Pre-Booking Success

    Initial interest in electric vehicles has been very strong, with interest expected to grow as GTEC expands its catalogue of offerings with the introduction of new electric vehicles and raising of awareness. The upcoming launches are expected to be highly disruptive in the absence of alternative industrial electric vehicles on the market. The opening of pre-bookings allows customers to incorporate products into their existing budget cycles as forecasts while offering the company increased visibility and ramp production.

    GEL-1800 Electric Loader

    The company’s GEL-1800 Electric Loader boasts a loading capacity of almost 1800 kg and is equipped with an impressive 144 kWh lithium battery. The vehicle is designed to be used in a myriad of applications, including, but not limited to, construction, mining, farming, and industrial.

    GEX-Electric Excavator

    The GEX-Electric Excavator, on the other hand, is an 8 ton electric excavator with the power to get the toughest of jobs done without the generation of the pollution associated with traditional internal combustion engines. The absence of carbon emissions generated through the operation of the GEX-8000 points to a safer option for the workplace, operators, and the local community.

    Future Outlook for GTEC

    Armed with the pending commercialization and proliferation of its new products in a market that is ripe for the taking, GTEC is poised to continue its trajectory of success. The company is keen to usher in further growth as it continues to push for increased market penetration. Current and potential investors are hopeful that management will continue to leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.

  • Why Is Trevena (TRVN) Stock Up in Pre-Hour Trades?

    Why Is Trevena (TRVN) Stock Up in Pre-Hour Trades?

    The shares of Trevena Inc. (TRVN) were up 6.44% in premarket trading at $2.15. TRVN stock closed at $2.02 yesterday, down -8.18% or $0.18. TRVN stock fluctuated between $2.01 and $2.18 on the day.

    TRVN stock traded at 2.63 million shares, less than the company’s average daily volume of 3.22 million during its 50-day period. On the resumption of patient recruitment by the NIH, TRVN stock jumped.

    Why were patients recruited?

    Trevena focuses on the development and commercialization of innovative drugs for patients with diseases related to the central nervous system (CNS). OLINVYK (oliceridine) injection is TRVN’s only U.S.-approved product. As an opioid analgesic, OLINVYK has been indicated in the treatment of acute pain in adults who are unable to be managed using alternative treatments.

    As announced by Trevena today, NIDA is once again recruiting patients for TRV734, the Company’s novel mu-opioid receptor selective agonist.

    • TRVN has been collaborating with NIDA to evaluate TRV734 as a potential treatment for opioid use disorder (OUD).
    • The TRVN study was halted in March 2020 due to the global COVID-19 pandemic.
    • Despite COVID-19, opioid use disorder is an urgent public health issue that must be addressed.
    • In order to meet the needs of opioid addicted individuals, it is important to continue to develop effective treatments.

    TRN plans to go further:

    NIDA’s willingness to re-open the TRV734 study, which may present a treatment option that is effective and more tolerable than the current recommendations, demonstrates the unmet need for OUD medicines. Trevena (TRVN) will leverage this collaboration to explore several pipeline assets in the NIH.

  • On What Basis Did ADOM Stock Rise 10%?

    On What Basis Did ADOM Stock Rise 10%?

    Last session, ADOMANI Inc. (OTCQB: ADOM) closed at $0.2704 after seeing its share price rise 10.37%, bringing its market cap to $78.50M. Recent activity on ADOMANI stock with trades of 854.51K shares has been lower than its average daily volume of 1.53M.

    Further, the ADOM stock price has been fluctuating between $0.2350 and $0.2748. In the pink sheets company, there are 290.32 million outstanding shares versus 44.71 million outstanding shares. After signing a factory representative agreement, ADOM stock rose.

    ADOM has signed an agreement with whom?

    ADOMANI was formerly known as Envirotech Vehicles and is an automotive manufacturer of zero-emission electric vehicles focused on reducing total costs of ownership and assisting fleet operators in implementing green technology.

    As an electric vehicle manufacturer, ADOM provides a range of solutions to the public, private and school sectors, as well as colleges and universities. In addressing fuel cost volatility and environmental regulations on local, state, and federal levels, ADOM vehicles offer an alternative.

    Earlier this month, Envirotech Vehicles (ADOMANI) announced it had signed a Factory Authorized Representative Agreement with Joseph Holdings, Inc.

    • Through the partnership, Joseph Holdings will be able to market, sell, and service Envirotech products throughout the Caribbean.
    • A minimum of one van and one truck belonging to the Class 4 or Class 5 must be purchased by Joseph Holdings at the beginning of the agreement.
    • At first, the cars will be used for demonstrations and could be sold to other customers.

    How will the partnership benefit ADOM?

    Through its partnership with Joseph Holdings, ADOMANI (ADOM) is able to leverage the Joseph Holdings’ established customer base and leasing capabilities as it looks to expand in the region. ADOM’s expansion plans in these markets will be enhanced by its relationship with Joseph Holdings, and this is a key catalyst to that expansion.

  • What Explains 10% Rise In MNKD Stock In Premarket Session Today?

    What Explains 10% Rise In MNKD Stock In Premarket Session Today?

    At the last check today, MannKind Corporation (MNKD) had reached $4.48, good for an increase of 9.27% in premarket session. The MannKind stock price dropped -0.73% to $4.10 at the end of the last trading session. MNKD stock price ranged between $4.08 and $4.18. MNKD stock surged on approval of its drug by authorities.

    In what way did the achievement succeed?

    MannKind specializes in developing and commercializing inhaled therapeutic products for patients with endocrine and orphan lung diseases. Afrezza Inhalation Powder is currently being sold by MNKD. As the only mealtime insulin available in the United States that is inhaled and acts very quickly, Afrezza is MNKD’s first FDA-approved product. All pharmacies in the United States offer the drug on prescription.

    The US Food and Drug Administration (FDA) today accepted the New Drug Application (NDA) for priority review submitted by MannKind and United Therapeutics Corporation (Nasdaq: UTHR). Tyvaso DPI (inhaled treprostinil) from MNKD has been given a priority review status for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung diseases (PH-ILD).

    MNKD’s Technosphere technology is being used to formulate the second compound to be reviewed by the FDA, which should be completed in October 2021. Also, FDA officials have said they haven’t found any issues with the review process at the moment.

    MNKD moving forward:

    This important step will allow MannKind (MNKD) to produce the next Technosphere product more conveniently for thousands of PAH and PH-ILD patients. As of September 2018, MNKD and United Therapeutics have signed an exclusive licensing and collaboration agreement for Tyvaso DPI.

    MNKD’s Tyvaso DPI manufacturing facility will be inspected by the FDA before the FDA approves the Tyvaso NDA. In the third quarter of 2021, FDA and MNKD plan to complete the inspections.