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Tag: FDA

  • ATXI Stock Is Down Today Before Market Open. Why?

    Avenue Therapeutics Inc. (ATXI) shares fell -45.84% to $2.28 in premarket trade today. Last trading session, Avenue stock has fallen -3.44% to $4.21. ATXI stock retreated even more -8.17% in the last five days but gained 2.93% over the past month. Before market open this morning, ATXI stock fell after the US Food and Drug Administration (“FDA”) rejected its new drug application (NDA).

    The NDA was for which drug?

    The mission of Avenue Therapeutics is to develop IV tramadol. US patients suffering from acute pain may be able to decrease their reliance on conventional opioids with IV tramadol. Avenue was formed by the Fortress Biotech Corporation in New York City.

    Today, Avenue announced that the FDA has sent a second Complete Response Letter (“CRL”) in connection with its application for approval of IV tramadol.

    • The CRL concluded that IV tramadol’s delayed and unpredictable onset of analgesia does not support its use as a monotherapy to treat acute pain.
    • Furthermore, the CRL stated that there is not enough information to support the combination of ATXI’s painkiller with other analgesics being safe and effective for the intended population.
    • In this CRL, the FDA highlighted no Chemistry, Manufacturing, and Controls (“CMC”) issues in ATXI’s candidate.
    • An October decision by the health regulator had rejected approval for the ATXI’s painkiller due to its unsuitability for the intended users.

    ATXI’s stance:

    The FDA’s interpretation of the data in the NDA is not consistent with Avenue (ATXI)’s position, said the company in its statement. ATXI once again committed to continue seeking regulatory approval for IV tramadol.

  • Equillium (NASDAQ: EQ) Gets FDA Green Signal To Start Phase 3 COVID-19 Trial

    Equillium (NASDAQ: EQ) Gets FDA Green Signal To Start Phase 3 COVID-19 Trial

    Shares of Equillium, Inc. (NASDAQ: EQ) soared 28.50% in the pre-trading hours after the company announced that it has got the ‘Study May Proceed Letter’ from the US Food and Drug Administration (FDA). After receiving a green signal from the FDA biotechnology company is planning to commence the COVID-19 Phase III trial, titled EQUINOX.

    In the EQUINOX Phase III trial, the company will officially enroll a total of 800 patients in the fourth quarter of 2020. FDA has also specified that the promising result of the study will also support the regulatory filing of a Biologic License Application (BLA).

    Equilium, Inc. (NASDAQ: EQ) shares were trading up 33.00% at $7.93 at the time of writing on Friday. It has a trading volume of 2.02 million in the pre-market trading session on Friday. Equilium, Inc. (EQ) share price went from a low point of around $2.20 to briefly over $27.05 in the past 52 weeks. It has moved up 172.73% from its 52-weeks low and moved down -77.82% from its 52-weeks high. EQ  market cap has remained high, hitting $144.84 million at the time of writing.

    Itolizumab is a clinical-stage, first-in-class monoclonal antibody that selectively targets the CD6-ALCAM pathway. It is used to treat COVID-19 patients suffering from Acute Respiratory Distress Syndrome (ADS). Itolizumab has the ability to control cytokine cascade that is the basis of multiple complications in COVID-19 Patients. Patients have experienced various complications such as organ failure, blood clots, and tissue damage.

    COVID-19 is continuously spreading all over the world and has infected many patients all around the globe.  Equillium is striving to provide treatment to COVID-19 patients. In the Phase III trial, patients will get either placebo or Itolizumab and they will get up to two doses of either placebo or Itolizumab on Day 1 and Day 8 if necessary.

    All the patients will be closely monitored through Day 28 while hospitalized or through post-discharge follow-up. The main purpose of this study is to evaluate the benefits of itolizumab. The trial will also analyze the safety, tolerability, and pharmacokinetics (PK) of itolizumab.

     

     

     

  • TRACON Pharmaceuticals (NASDAQ: TCON) Receives FDA TRC102 Orphan Drug Designation

    TRACON Pharmaceuticals (NASDAQ: TCON) Receives FDA TRC102 Orphan Drug Designation

    TRACON Pharmaceuticals, Inc. (NASDAQ: TCON) has announced today that it has received Orphan Drug Designation for TRC102 for the treatment of patients suffering from malignant Glioma and glioblastoma (GBM) from the US Food and Drug Administration (FDA). In the Orphan Drug Designation, the drug has been given the Orphan status. This status is given to the companies to provide them with financial benefits for the development of new drugs for the treatment of rare diseases.

    TRC102 is being examined in Phase 1 and Phase 2 clinical trials which were sponsored by the National Cancer Institute through a Cooperative Research and Development Agreement (CRADA). In Phase II, TRC102 was analyzed with Temodar chemotherapy. This study has been done on 19 patients who were suffering from progressive or recurrent GBM.

    Thes study has shown promising results and increase the time of survival in two patients for more than two years. Both patients have shown the activation of the DNA base excision repair pathway and shown hyperactivation of DNA damage response genes.

    Furthermore, TRC102 has also been analyzed in combination with chemotherapy and external beam radiotherapy in a Phase 1 study. 15 patients have participated in this study who have newly diagnosed non-squamous cell non-small cell lung cancer.

    TRACON Pharmaceuticals, Inc. (NASDAQ: TCON) shares were trading up 9.29% at $4.94 during the trading session of Friday. TRACON Pharmaceuticals, Inc. (TCON) share price went from a low point around $0.95 to briefly over $6.37 in the past 52 weeks. It has traded up 420.00% from its 52-weeks low and moved down -22.45% from its 52-weeks high. TCON market cap has remained high, hitting $59.58 million at the time of writing.

    Orphan Drug Designation status for TRC102 will be helpful in providing the treatment for unmet medical needs of patients who are suffering from malignant glioma. TRACON Pharmaceuticals has committed to developing TRC102 with the help of the National Cancer Institute.

  • TG Therapeutics (NASDAQ: TGTX) Ublituximab Receives Fast Track Designation In US

    TG Therapeutics (NASDAQ: TGTX) Ublituximab Receives Fast Track Designation In US

    TG Therapeutics, Inc. (NASDAQ: TGTX) has announced Wednesday that it has received the Fast Track Designation for its ublituximab/umbralisib combo for the treatment of adult patients with chronic lymphocytic leukemia (CLL) from the FDA.

    Fast Track is basically the program developed to speed up the review of drugs that treat serious diseases and address unmet medical needs. Filling an unmet medical need is to provide the treatment for those diseases for which no medical treatment is available earlier or offering a medical treatment that may be better than available therapy.

    TG Therapeutics, Inc. (NASDAQ: TGTX) shares were trading up 0.31% at $28.75 at the time of writing on Wednesday. TG Therapeutics, Inc. share price went from a low point around $5.38 to briefly over $31.97 in the past 52 weeks, though shares have since pulled back to $28.75. TGTX market cap has remained high, hitting $334.37M at the time of writing.

    The application of Fast Track designation is based on the data from UNITY-CLL Phase 3 study. The company has announced earlier in UNITY-CLL Phase 3 data that the treatment has shown a positive result. This Fast Track Designation is very important for the company. UNITY-CLL Phase 3 is the study to analyze the combination of ublituximab and umbralisib. Ublituximab is a glycoengineered anti-CD20 monoclonal antibody, and umbralisib is a dual inhibitor of PI3K-delta and CK1-epsilon.

    Chronic lymphocytic leukemia (CLL) is a serious issue in the current period as more than 20,000 new cases have been reported alone in the US. After initial treatment, its symptoms disappear for a period of time but the disease is considered incurable. People need additional treatment after the return of the malignant cells.

  • Why Adial Pharmaceuticals (NASDAQ: ADIL) Is Soaring Today?

    Why Adial Pharmaceuticals (NASDAQ: ADIL) Is Soaring Today?

    Shares of Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) traded up 114.89% after the company announced that it has received the Emergency Use Authorization (EUA) from FDA for Assure/FaStep® COVID-19 IgG/IgM Rapid Test Device. This Emergency Use Authorization from the FDA is the first antibody point-of-care test for COVID-19.

    The rapid test device, the blood samples were used using fingerstick as compared to other approved tests which are recently using only plasma, serum, or venous blood. After the authorization from FDA, fingerstick blood samples can be used with the FaStep COVID-19 IgG/IgM Rapid Test Device for the test in point-of-care settings, including urgent care centers, emergency rooms, doctors’ offices, hospitals, or other locations where there is a licensed healthcare professional.

    Previously, this FaStep COVID-19 IgG/IgM Rapid Test Device is used for the detection of SARS-CoV-2 antibodies in the individuals and it is used to identify the recent or previous COVID-19 infection. Various other kits were present but they haven’t got the authorization for the fingerstick blood sample.

    Shares of Adial Pharmaceuticals soared 114.89% after it gained +1.62 during the trading session of Tuesday. It has a closing price of $3.03. In the past 52-weeks of trading, this company’s stock fluctuated between the low of $1.00 and a high of $3.17. It has moved up to 203.00% from its 52-weeks low and moved down -4.42% from its 52-weeks high. Looking at its liquidity, it has a current ratio of 13.90. This company’s market capitalization has remained high, hitting $41.06 million at the time of writing.

    Adial has announced that it has started the sales of the FaStep COVID-19 IgG/IgM rapid antibody test kits to healthcare providers and hospitals through The iRemedy Healthcare Companies, Inc. (iRemedy) network and e-commerce platform. This company has earlier filed for Expedited Review of AD04 with the FDA. AD04 is the drug candidate used for the treatment of Alcohol Use Disorder (AUD)

  • Here’s Why You Should Hold AcelRx (NASDAQ: ACRX) Stock In Your Portfolio

    Here’s Why You Should Hold AcelRx (NASDAQ: ACRX) Stock In Your Portfolio

    AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX) stock surged 15.29% on Monday. The drug manufacturer company earlier revealed that it has secured a contract from the US Army.  The U.S. Army has granted an initial contract of up to approximately $3.6 million for the purchase of DSUVIA to support a study to aid the development of clinical practice guidelines to AcelRx Pharmaceuticals.

    As per the agreement, the initial purchase is expected this year and the company will be able to fulfill the orders mentioned in the agreement in the next four years as per the agreement conditions. DSUVIA’s high therapeutic index, unique pharmacokinetic profile, and efficient sublingual delivery will make it as a key option for acute pain management across all branches of the military.

    DSUVIA which is also known as DZUVEO has received approval from the FDA in 2018. This medicine is used for the management of severe pain which required an opioid analgesic, and for which alternative treatments are not enough.  DSUVIA is a single-strength solid dosage form inject under the tongue via a single-dose applicator (SDA) by healthcare professionals.

    AcelRx Pharmaceuticals, Inc. (NASDAQ: ACRX)  shares were trading up 15.29% at $1.81 at the time of writing on Monday. AcelRx Pharmaceuticals, Inc. (ACRX) share price went from a low point around $0.70 to briefly over $2.68 in the past 52 weeks. It has traded up 158.06% from its 52-weeks low and traded down -32.46% from its 52-weeks high. ACRX market cap has remained high, hitting $142.61 million at the time of writing.

    AcelRx has earlier announced that all the branches of the military will be able to access DSUVIA. The company has added the DSUVIA to the Department of Defense Joint Deployment Formulary (JDF). The JDF is a basic list of pharmaceutical products designated for the deployment of military units in all service branches.

    The company has earlier participated in H.C. Wainwright & Co. 22nd Annual Global Investment Conference and Cantor Fitzgerald Virtual Global Healthcare Conference on September 14, and 16, respectively.

  • Why Arrowhead Pharmaceuticals (NASDAQ: ARWR) Skyrocketed Today?

    Why Arrowhead Pharmaceuticals (NASDAQ: ARWR) Skyrocketed Today?

    Shares of Arrowhead Pharmaceuticals, Inc. (NASDAQ: ARWR) traded up 40.33% on Wednesday after it revealed the data on the drug to treat liver disease. Arrowhead has shared the positive interim 24-week liver biopsy results in four volunteers of AROAAT2002. AROAAT2002 is the open-label phase 2 clinical study of ARO-AAT. ARO-AAT is the investigational drug that is developed for the treatment of rare-genetic liver diseases. The rare liver disease is analogous with alpha-1 antitrypsin deficiency (AATD).

    The biotechnology company has revealed that the result of the study showed improvement in liver stiffness. The clinical trial has unveiled the positive effects of ARO-AAT as the company saw a reduction in intra-hepatic mutant AAT protein (Z-AAT), both Z-AAT monomer and Z-AAT polymer.  Participants have undergone the treatment for 24 weeks and all have shown the 93% to 95% drop in intrahepatic Z-AAT. Moreover, three of four patients have shown a 97% reduction in Z-AAT.

    Arrowhead earlier expected that the 6 months treatment with ARO-AAT will reduce both Z-AAT monomer and Z-AAT polymer but the 24 weeks treatment data has shown the results which are more than the expectations. The company is planning to discuss with the FDA and other regulatory agencies to speed up the clinical trial.

    Shares of Arrowhead Pharmaceuticals (NASDAQ: ARWR) soared 40.33% as it gained +13.63 at $47.43 during the trading session of Wednesday. In the past 52-weeks of trading, this company’s stock has fluctuated between the low range of $19.51 and a high range of $73.72. Arrowhead has traded up 143.10% from its 52-weeks low and traded down -35.66% from its 52-weeks high.  This company’s market capitalization has remained high, hitting $5.14 billion at the time of writing.

    The positive result from the 24-week treatment showed that the ARO-AAT will soon improve the liver injury. This encouraging result has also given hope to the Alpha-1 community in the midst of an ongoing pandemic.

    Arrowhead is currently working on the therapy, RNAi, that other companies have successfully commercialize. It has also licensed its therapies to various leading companies.  It is too early to say that it will get the EU or FDA approval but there are chances that the company will receive the approval as it has shown the positive results of phase 2 clinical study of ARO-AAT.

    Arrowhead three most advanced drugs include  ARO-AAT, a treatment for liver disease. The company has recently provided promising results from its phase 2, the second one is JNJ-3989 which is licensed to Janssen and it is the potential treatment for hepatitis B. It has earlier reported the data which also showed the encouraging result. The third one is the AMG 890. AMG 890 has the ability to decrease the production of apolipoprotein A which is genetically linked with increased risk of atherosclerosis and related cardiovascular diseases.

     

  • Should You Invest In Inovio Pharmaceuticals (NASDAQ: INO)?

    Should You Invest In Inovio Pharmaceuticals (NASDAQ: INO)?

    Inovio Pharmaceuticals, Inc. (NASDAQ: INO), a biotechnology company has recorded an increase of 35.88% in its shares price as it has gained +4.89 on Wednesday. Inovio Pharmaceuticals has earlier participated in H.C. Wainwright 22nd Annual Global Investment Conference on September 14 where its CEO J. Joseph Kim has made two statements that excited its investors.

    CEO J. Joseph disclosed that the Phase 1 study of its coronavirus vaccine candidate INO-4800 is currently in the peer review. He also revealed that the Inovio will soon announce the result of peer review in the coming weeks. Secondly, Inovio’s CEO said that the company is planning to start phase 2/3 testing for its investigational vaccine. The biotech company is waiting for the FDA approval for phase 2/3 which the company expects will happen soon. Inovio said that it is confident that it will receive the funding for the upcoming trials of the vaccine.

    Inovio Pharmaceuticals is scheduled to participate in the upcoming two conferences including Cantor Global Healthcare Conference on September 17 and Oppenheimer Fall Healthcare Life Sciences & MedTech Summit which will take place on September 23. Investors expected that the biotechnology company will announce the exciting news soon.

    Inovio Pharmaceuticals (NASDAQ: INO) shares were trading up 35.88% at $18.52 at the time of writing on Thursday.  INO share price went from a low point around $1.91 to briefly over $33.79 in the past 52 weeks. It has moved up 867.10% from its 52-weeks low and moved down -45.19% from its 52-weeks low. If we look at its liquidity, it has a current ratio of 10.10. Inovio market cap has remained high, hitting $2.99 billion at the time of writing.

    The company has earlier shared the result from the Phase 1 clinical trial of the coronavirus vaccine candidate but the industry investors were not satisfied with the result as the company didn’t give any details about immune responses in patients. But it is expected that the upcoming peer review could clear the doubts of industry observers.

    Shares of Inovio Pharmaceuticals has experienced an unusual options activity on Wednesday trading session. The large volume is one option activity that is considered to be unusual. The volume of options activity means the number of shares contracts traded for a day. INO has experienced bullish sentiments which means to buy at/near ask price or a put is sold at/near bid price.

    Previously, Inovio Pharmaceuticals has signed a contract with Thermo Fisher Scientific for the development of a coronavirus vaccine candidate, INO-4800. Inovio is planning to make the 100 million doses of INO-4800 by 2021 after receiving FDA approval.

  • Is Pfizer Inc. (NYSE: PFE) A Good Investment?

    Is Pfizer Inc. (NYSE: PFE) A Good Investment?

    Shares of Pfizer Inc. (NYSE: PFE) traded up 2.61% after gaining +0.94 on Monday as it may be the first to disclose the late-stage study result from its trials with partner BioNTech SE. Pfizer Inc. is currently conducting one of the most advanced trials of a vaccine for novel coronavirus.

    It has commenced the Phase 2/3 study of BNT162b2, a most advanced coronavirus vaccine candidate in July. Almost 30,000 participants were enrolled in the trial who received two doses of the vaccine candidate.

    Pfizer CEO Albert Bourla revealed that the FDA committee will gather to discuss vaccines on Oct 22. CEO said that the company has a deep understanding of this matter and it will be able to present the efficacy data of Phase 3 before the end of October.

    He said that the company is not bound to any deadline. Albert Bourla said that FDA is searching for companies to review their vaccines that are at least 50% effective. Pfizer is hoping for a better result as its Phase 3 trial with 30,000 people is almost completed.

    Goldman Sachs labeled this a vaccine trade as the investors were attracting towards stocks that were developing a vaccine or any treatment of diseases and they dumped the stock soon after hearing the good news. The same thing happened with Gilead Sciences as its shares tumbled down after it has got the regulatory approval for its antiviral medicine of COVID-19.

    Pfizer Inc. (NYSE: PFE) share price went from a low point around $27.88 to briefly over $40.97 in the past 52 weeks, though shares have since pulled back to $37.01. Pfizer Inc. has moved up 32.75% from its 52-weeks low and moved down -9.67% from its 52-weeks high. Pfizer Inc.’s market cap has remained high, hitting $203.27 billion at the time of writing. If we look at its liquidity, it has a current ratio of 1.40.

    Pfizer Inc and BioNTech SE have recently disclosed that they striving to secure the approval of the US FDA to expand the late-stage clinical trial of their COVID-19 vaccine. Earlier, Pfizer has enrolled the 30,000 participants in the trial but now it is looking for the trial which will enroll 44,000 volunteers as the company is trying to add the young population in the late-stage study.

    Previously, the US Government has revealed that it would pay $1.95 billion to companies for the supply of 100 million doses of vaccine if it received regulatory approval. CEO Pfizer also disclosed that the company has invested $1.5 billion for the development of a vaccine and if the trial is not successful it is painful for the company.

  • Is Aemetis (NASDAQ: AMTX) A Good Stock To Buy Right Now?

    Is Aemetis (NASDAQ: AMTX) A Good Stock To Buy Right Now?

    Aemetis, Inc. (NASDAQ: AMTX), a renewable fuels and biochemicals company disclosed it has received the National Drug Code (NDC) from the US Food and Drug Administration (FDA) for the production of Over The Counter (OTC) Sanitizer products.

    Aemetis is the producer of high-grade sanitizer alcohol. This FDA registration is an important opportunity for Aemetis to expand its business as the global market for sanitizer products and hand sanitizers have made progress rapidly because of the coronavirus pandemic.

    Aemetis (AMTX) share price went from a low point around $0.37 to briefly over $3.47 in the past 52 weeks, though shares have since pulled back to $2.04. It has soared 22.89% after gaining more than +0.38 on Tuesday. It has a day low range of $1.80 and a day high range of $2.68.

    AMTX market capitalization has remained high, hitting 42.62 million at the time of writing. It had a trading volume of 34.04 million as compared to the average volume of 1.68 million. Looking at its profitability, it has a return on assets (ROA) of -21.70%, return on equity (ROE) OF 14.70%, and return on investment (ROI) of -18.80%.

    The Gross Margin of Aemetis is 11.90%, Profit Margin is -11.60%, and an Operating Margin is 3.00%. AMTX had traded up 450.61% from its 52-weeks low and traded down -41.21% from its 52-weeks high. This company has recorded sales of 196.80 million. If we look at the liquidity of Aemetis, it has a current ratio of 0.30. Its quick ratio has remained as 0.20.

    Aemetis has gained a competitive edge as it is the only large scale producer of high-grade sanitizer alcohol in the Western United States. Aemetis has decided to meet all the ongoing demands for alcohol wipes, hand sanitizers,  and other sanitizer products under the Aemetis Health Products brand and on a private label basis.

    Earlier, it has disclosed that it has completed the construction of the first two dairy digesters and four-mile pipeline for the production of renewable natural gas (RNG). Aemetis aimed to provide the below zero carbon intensity RNG to replaced petroleum-based natural gas.