The Daily Biotech Pulse: Sanofi Buys Translate Bio In $3.2B Deal, Lilly's Q2 Earnings Disappoint, Bausch To Spin Off Medical Aesthetics Business - iShares Biotechnology ETF (NASDAQ:IBB)

Here's a roundup of top developments in the biotech space over the last 24 hours:

Scaling The Peaks

(Biotech Stocks Hitting 52-week Highs Aug. 2)

Absci, CORP ABSI (IPOed July 22)
Alkermes plc ALKS (received fast track designation for nemvaleukin alfa for the treatment of mucosal melanoma)
AtriCure, Inc. ATRC
Axonics, Inc. AXNX
Bio-Rad Laboratories, Inc. BIO
BioNTech SE BNTX
Boston Scientific Corporation BSX
Cytek Biosciences, Inc. CTKB (IPOed July 23)
Imago BioSciences, Inc. IMGO (IPOed July 16)
Innoviva, Inc. INVA
Intuitive Surgical, Inc. ISRG
Misonix, Inc. MSON
Moderna, Inc. MRNA
Monte Rosa Therapeutics, Inc. GLUE
Novo Nordisk A/S NVO
Nuvalent, Inc. NUVL (IPOed Thursday)
Pfizer Inc. PFE
Protagonist Therapeutics, Inc. PTGX
Quest Diagnostics Incorporated DGX
Repligen Corporation RGEN
Sight Sciences, Inc. SGHT (IPOed July 15)
West Pharmaceutical Services, Inc. WST

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Aug. 2)

23andMe Holding Co. ME
Adicet Bio, Inc. ACET
Adverum Biotechnologies, Inc. ADVM
Cogent Biosciences, Inc. COGT
Esperion Therapeutics, Inc. ESPR
EyeGate Pharmaceuticals, Inc. EYEG
Foghorn Therapeutics Inc. FHTX
Gain Therapeutics, Inc. GANX
Icosavax, Inc. ICVX (IPOed Thursday)
Immunovant, Inc. IMVT (announced $200-million equity investment from Roivant Sciences)
Minerva Neurosciences, Inc. NERV (reacted to second-quarter results)
Nautilus Biotechnology, Inc. NAUT
NexImmune, Inc. NEXI
Outset Medical, Inc. OM
Oyster Point Pharma, Inc. OYST
Palisade Bio, Inc. PALI
Plus Therapeutics, Inc. PSTV
Progenity, Inc. PROG
Revive Therapeutics Ltd. RVVTF
Rhythm Pharmaceuticals, Inc. RYTM
Spruce Biosciences, Inc. SPRB
Theravance Biopharma, Inc. TBPH
Trillium Therapeutics Inc. TRIL
VectivBio Holding AG VECT
ZIVO Bioscience, Inc. ZIVO

Stocks In Focus

Sanofi To Buy mRNA Biopharma Translate Bio For $38/Share In Cash

Sanofi SNY said it has entered into a definitive agreement with Translate Bio, Inc. 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 Withdraws Istodax From US In Peripheral T-Cell Lymphoma

Bristol-Myers Squibb Company 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 Says FDA Lifts Clinical Hold On Spinal Muscular Atrophy Trials

Novartis AG 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's Tecentriq Regulatory Accepted For Regulatory Review As Adjuvant Treatment

Roche Holding AG 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 Healthcare To Spin Off Medical Aesthetics Business

Bausch Health Companies Inc. 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.

Marinus Files For Ganaxolona Approval In Seizures Associated With CDKL5 Deficiency Disorder

Marinua Pharmaceuticals, Inc. 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 Gets Regulatory Nod In Singapore For Clinical Study Of 2 mRNA Vaccines

Arcturus Therapeutics Holdings Inc. 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's Drug Combo Aces Late-Stage Retinal Disorder Study

Outlook Therapeutics, Inc. 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 Reports Positive Results For Phase 1 Asset In Fibrotic Diseases, FDA Approves Midstage Kidney Disease Study

Angion Biomedica Corp 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 Announces Clinical Collaboration To Develop Companion Diagnostics For Drugs

Burning Rock Biotech Limited 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.

Offerings

Avidity Biosciences, Inc. RNA filed a preliminary prospectus with the FDA for offering $100 million worth of its common stock.

On The Radar

Earnings

Eli Lilly and Company LLY (Q2 Revenues Up 23% at $6.74 billion and non-GAAP EPS at $1.87 Vs. consensus of $1.92 and $6.65 billion, , FY21 guidance lowered)
X4 Pharmaceuticals, Inc. XFOR (before the market open)
Rhythm Pharma (before the market open)
Myriad Genetics, Inc. MYGN (before the market open)
Seres Therapeutics, Inc. MCRB (before the market open)
Neuronetics, Inc. STIM (before the market open)
Kiniksa Pharmaceuticals, Ltd. KNSA (before the market open)
ADC Therapeutics SA ADCT (before the market open)
Aptose Biosciences Inc. APTO (after the close)
Theravance Biopharma, Inc. TBPH (after the close)
Pulmonx Corporation LUNG (after the close)
Invitae Corporation NVTA (after the close)
Cytosorbents Corporation CTSO (after the close)
Rigel Pharmaceuticals, Inc. RIGL (after the close)

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