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Here's a roundup of top developments in the biotech space over the last 24 hours:
(Biotech Stocks Hitting 52-week Highs Aug. 2)
(Biotech Stocks Hitting 52-week Lows Aug. 2)
Sanofi (NASDAQ:SNY) said it has entered into a definitive agreement with Translate Bio, Inc. (NASDAQ:TBIO), a clinical-stage mRNA therapeutics company, under which Sanofi will acquire all outstanding shares of Translate Bio for $38 per share in cash, which represents a total equity value of approximately $3.2 billion.
"A fully owned platform allows us to develop additional opportunities in the fast-evolving mRNA space. We will also be able to accelerate our existing partnered programs already under development. Our goal is to unlock the potential of mRNA in other strategic areas such as immunology, oncology, and rare diseases in addition to vaccines, said Paul Hudson, CEO of Sanofi.
Translate Bio shares were jumping 29.5% to $37.75 in premarket trading, while Sanofi was near-flat at $51.59.
Bristol-Myers Squibb Company (NYSE:BMY) said it has decided to withdraw Istodax for the indication of peripheral T-cell lymphoma in the U.S. The decision follows a subsequent confirmatory Phase 3 study evaluating Istodax plus CHOP versus CHOP in first-line PTCL patients, failing to meet the primary efficacy endpoint of progression-free survival.
The company had earlier received accelerated approval by the Food & Drug Administration for Istodax as a monotherapy for the treatment of peripheral T-cell lymphoma in adult patients who have received at least one prior therapy.
Novartis AG (NYSE:NVS) said the FDA has determined that OAV-101 intrathecal clinical trials for spinal muscular atrophy patients may proceed, thereby lifting the partial clinical trial hold initiated in October 2019.
The decision to lift the hold was based on data from Novartis' comprehensive nonclinical toxicology study in non-human primates that addressed all issues identified, including questions of dorsal root ganglia injury following IT administration, the company said.
Following this decision and input from the FDA and European Medicines Agency, Novartis said it now plans to initiate STEER, a global pivotal Phase 3 registration-enabling study to evaluate the clinical efficacy, safety and tolerability of OAV-101 IT in treatment naïve patients who are between two and 18 years of age, able to sit, but have never walked.
The stock was up 0.68% at $92.90 in premarket trading.
Roche Holding AG (OTC:RHHBY) said the FDA has accepted the company's supplemental biologics license application and granted priority review for Tecentriq as adjuvant treatment following surgery and platinum-based chemotherapy for people with non-small cell lung cancer whose tumours express PD-L1 less than or equal to 1, as determined by an FDA-approved test.
The FDA is expected to make a decision on approval by Dec. 1.
Bausch Health Companies Inc. (NYSE:BHC) announced that it plans to pursue an initial public offering of its Solta Medical business.
Solta is a leading global provider in medical aesthetics with innovative and effective skin rejuvenation and body contouring solutions, including the Thermage RF systems, Fraxel laser, Clear + Brilliant laser and VASER ultrasonic systems.
Separately, the company reported second-quarter revenues that were shy off estimates and lowered its full-year guidance.
The shares were down 3.14% at $28.72 in premarket trading.
Marinua Pharmaceuticals, Inc. (NASDAQ:MRNS) announced the submission of a NDA to the FDA for the use of its lead product candidate ganaxolone to treat seizures associated with CDKL5 deficiency disorder, a rare, genetic epilepsy.
A NDA filing notification letter from the FDA is expected before the end of the third quarter. If the NDA is accepted for filing, this will enable the company to draw $30 million of additional cash under its credit financing agreement with Oaktree Capital Management, on or before Dec. 31, the company said.
In premarket trading, the stock was up 6.18% at $15.97.
Arcturus Therapeutics Holdings Inc. (NASDAQ:ARCT) announced that the it has received approval for a Clinical Trial Application from the Singapore Health Sciences Authority to enable the advancement of two STARR mRNA vaccine candidates into the clinic.
The Phase 1/2 clinical trial will evaluate the vaccines both as a primary vaccination series and as a booster following initial vaccination with Comirnaty. The Phase 1/2 trial costs are funded in part from a previously secured grant from Singapore.
The stock was gaining 7.07% to $37.11 in premarket trading.
Click here to access Benzinga's FDA Calendar
Outlook Therapeutics, Inc. (NASDAQ:OTLK) announced positive clinical and highly statistically significant topline results from its pivotal Phase 3 safety and efficacy trial evaluating ONS-5010/Lytenava for treatment of neovascular age-related macular degeneration.
The stock was climbing 28.76% at $2.91 in premarket trading.
Angion Biomedica Corp (NASDAQ:ANGN) announced positive results from its Phase 1 study in healthy volunteers for ANG-3070, a novel oral tyrosine kinase receptor inhibitor being developed for the treatment of fibrotic diseases.
Angion also announced FDA acceptance of an investigational new drug application supporting the initiation of a Phase 2 trial in patients with primary proteinuric kidney diseases in 2021.
Burning Rock Biotech Limited (NASDAQ:BNR) announced a global strategic partnership with IMPACT Therapeutics in companion diagnostics development for a pipeline of drugs in the field of synthetic lethality. The two companies will jointly develop CDx for a targeted oncology drug, Senaparib, a PARP inhibitor, for the treatment of prostate cancer globally, including CDx submissions to both the FDA and the National Medical Products Administration of China.
Furthermore, the two companies will deepen collaborations in exploring and discovering new biomarkers for a pipeline of targeted drugs.
Avidity Biosciences, Inc. (NASDAQ:RNA) filed a preliminary prospectus with the FDA for offering $100 million worth of its common stock.
Related Link: Attention Biotech Investors: Mark Your Calendar For August PDUFA Dates
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