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The Daily Biotech Pulse: Sarepta Gene Therapy Data, Idera Dives on Failed Skin Cancer Study, 3 IPOs
Here is an overview of the best developments in the biotechnology space over the past 24 hours. Scaling The Peaks (Biotech shares hit 52-week highs on March 18) AngioDynamics, Inc. (NASDAQ: ANGO) Anixa Biosciences, Inc. (NASDAQ: ANIX) ENDRA Life Sciences Inc. (NASDAQ: NDRA) (Announces Collaboration with Hepion Pharmaceuticals, Inc. (NASDAQ: HEPA) for NASH Studies) Harvard Bioscience, Inc. (NASDAQ: HBIO) Neos Therapeutics, Inc. (NASDAQ: NEOS) (responded to shareholders’ meeting to vote on merger proposal with Aytu BioScience, Inc. (NASDAQ: AYTU)) NuVasive, Inc. (NASDAQ: NUVA) SI-BONE, Inc. (NASDAQ: SIBN) Sierra Oncology, Inc. (NASDAQ: SRRA) Silverback Therapeutics, Inc. (NASDAQ: SBTX) Terns Pharmaceuticals, Inc. (NASDAQ: TERN) Varian Medical Systems, Inc. (NASDAQ: VAR) Vericel Corporation (NASDAQ: VCEL) Vincerx Pharma, Inc. (NASDAQ: VINC) Down In The Dumps (Biotech shares hitting 52-week lows March 18) Foghorn Therapeutics Inc. (NASDAQ: FHTX) (a corporate update released) Galecto, Inc. (NASDAQ: GLTO) Voyager Therapeutics, Inc. (NASDAQ: VYGR) Stocks in focus Sarepta Pre sent Positive data for gene therapy for the treatment of limb muscular dystrophy Sarepta Therapeutics, Inc. (NASDAQ: SRPT) announced new results from the ongoing study of SRP-9003, its investigative gene therapy for limb type 2E muscle dystrophy, which has sustained protein expression in muscle tissue. Functional assessments taken two years after treatment in a low-dose arm and one year after treatment in a high-dose arm showed that patients continued to show stability in their NSAD total score and improvements over timely function tests. The results in both groups improve the safety and tolerance profile of SRP-9003, the company said. The results were presented today at the Muscular Dystrophy Association’s 2021 Annual Clinical and Scientific Conference. In the after-hours trading, the stock added 4.75% to $ 87.75. Cyclerion announces that Cyclerion Therapeutics, Inc. ‘s chief medical officer (NASDAQ: CYCN) is leaving, said Christopher Wright, chief medical officer, has resigned from his position at the company. Wright will provide Cyclerion with transitional support until March 26 and will also join the company’s clinical advisory board. vTv begins study to evaluate the potential of TTP399 in reducing ketoacidosis in type 1 diabetic patients vTv Therapeutics Inc. (NASDAQ: VTVT) has announced the start of a mechanistic study examining the effects of TTP399 on the formation of ketone bodies during a period of insulin withdrawal type 1 diabetes. According to the company, the phase 1 study will test the hypothesis that treatment with vTv’s TTP399 will not lead to increased production of ketones, which is a precursor to ketoacidosis, which could lead to hospitalization in patients with type 1 diabetes. Diabetic ketoacidosis is a serious complication of diabetes that occurs when the body produces high levels of blood acids, called ketones, when insulin production by the body is insufficient. The stock lost 3.91% to $ 2.70 in trading after hours. Incyte’s Jakafi Flunks A late-year study on the treatment of ARDS in COVID-19 patients Incyte Corporation (NASDAD: INCY) said that the Phase 3 DEVENT study evaluates the efficacy and safety of doses of Jakafi, 5 mg and 16 mg, plus standard care towards SoC in patients with mechanical ventilation with COVID-19 associated acute respiratory distress syndrome, it did not reach the primary endpoint. The improvement in mortality for each dose compared with placebo, although it tends to be positive, was not statistically significant for the total study population, the company said. However, there was a significant improvement in mortality seen in US participants at both doses and in the overall population when data from both treatment arms were pooled. The company said it would discuss with the FDA an extensive access program to qualify patients in the U.S. with COVID-19-associated ARDS to receive ruxolitinib. In the after-hours trading, the stock rose 1.06% to $ 79.08 in the after-hours trading. Idera Says Lead Medicine Flunks Skin Cancer Study In Late Stage Idera Pharmaceuticals, Inc. (NASDAQ: IDRA) stated that the ILLUMINATE-301 nuclear registration test of its main product candidate tilsotolimod in combination with Bristol-Myers Squibb Company’s Yervoy versus ipilimumab alone in patients with anti-PD-1 refractory advanced melanoma does not meet its primary endpoint of objective response rate. Idera said it is evaluating the next steps regarding the continuation of the trial to its overall endpoint for survival, which includes the complete dataset when available. The company also plans to continue its ILLUMINATE-206 phase 2 study of tilsotolimod in combination with ipilimumab and nivolumab in patients with micro-satellite stable colorectal cancer. View more earnings on IBB. The stock fell 59.88% to $ 2.01 after hours. Merck, Eisai reports positive data in the late stage for combination therapy in endometrial cancer Merck (NYSE: HRC) and Eisai Co., Ltd. (OTC: ESALY) announced positive data from the core phase 3 KEYNOTE-775 / Study 309 study evaluating the combination of the former’s Keytruda plus the latter’s Lenvima, for the treatment of certain patients with advanced, metastatic or recurrent endometrial cancer after following a previous platinum-based regime in any environment. The data were presented during an oral session at the Virtual Society of Gynecologic Oncology 2021 Annual Meeting on Women’s Cancer. Kiniksa Announces FDA Approval for Arcalyst in the Treatment of Auto-Inflammatory Cardiovascular Diseases Kiniksa Pharmaceuticals, Ltd. (NASDAQ: KNSA) said that the FDA has approved Arcalyst, a weekly, subcutaneous injected, recombinant fusion protein, for the treatment of recurrent pericarditis and the reduction of the risk of recurrence in adults and children 12 years and older. The company expects the drug to be launched in April 2021. Shares rose 10.50% to $ 24 after hours. Marker Therapeutics gains on insider purchases Marker Therapeutics, Inc. (NASDAQ: MRKR)’s shares moved upwards after a series of documents by the company revealed that insiders of the company had bought shares in the company. The stock rose 21.11% to $ 2.18 in after-hours trading. Earnings Alpine Immune Sciences, Inc. (NASDAQ: ALPN) reported an increase in its fourth-quarter revenue from $ 884,000 in 2019 to $ 5.64 million in 2020. The net loss per share decreased from 33 cents to 27 cents. The stock decreased 5.87% to $ 13 in trading after hours. On the Radar Clinical Readouts The Society of Gynecologic Oncology Meeting Presentations Aravive, Inc. (NASDAQ: ARAV): Updated data from Phase 1b trial evaluating AVB-500 in platinum-resistant ovarian cancer (15:35); In addition, a thesis should be presented on the phase 1/2 investigator trial of AVB-500 in combination with durvalumab in patients with platinum-resistant, recurrent epithelial ovarian cancer. Leap Therapeutics, Inc. (NASDAQ: LPTX): Additional Data from the Phase 2 Study of DKN-01 and Paclitaxel Chemotherapy Medications in Endometrial Cancer Earn Celsion Corporation (NASDAQ: CLSN) IPOs Finch Therapeutics Group, Inc., ‘Clinical Stage of Microbiome Therapy’ a new class of biologics administered orally, its initial public offering of 7.5 million shares priced ordinary shares at $ 17 per share, increasing a gross return of $ 127.5 million. The shares will start trading on the Nasdaq under the symbol FNCH. Biopharma Connect China-based Biopharma Holdings Ltd listed a stock exchange of 11.25 million ADs, representing 11.25 million ordinary shares of the company, at $ 17 per ADS. The gross proceeds of the offer are expected to be $ 191.3 million. The ADSs of the company that develops T cell therapies for chronic inflammatory diseases will start trading on the Nasdaq under the symbol CNTB. Instil Bio, Inc., a clinical-stage biopharmaceutical company that develops an innovative pipeline for cell therapy from autologous TIL therapies for the treatment of cancer patients, has expanded its large initial public offering of 16 million shares of ordinary shares at $ 20 per share praised. The gross proceeds of the offer are expected to amount to $ 320 million. The shares on the Nasdaq are expected to trade under the symbol TIL. Related link: Attention Biotech investors: mark your calendar for March PDUFA dates See more of Benzinga Click here for options dealing with Benzinga The Daily Biotech Pulse: Translate Bio’s Cystic Fibrosis Study Disappoints, Adverum names directors, get therapeutic factors to Nasdaq debut The Daily Biotech Pulse: Merck’s Keytruda gets a label expansion in Europe, Pfizer to sell Chinese biological unit, Celcuity Spikes © 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.