The Daily Biotech Pulse: Galapagos Sinks On Data, J&J Recalls Sunscreen Products, FibroGen Awaits AdCom Verdict, 3 IPOs

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 July 14)

• Alexion Pharmaceuticals, Inc. ALXN - U.K. antitrust regulators cleared its pending acquisition by AstraZeneca PLC AZN
• Bristol-Myers Squibb Company BMY
• Celldex Therapeutics, Inc. CLDX
• Moderna, Inc. MRNA
• PLx Pharma Inc. PLXP
• Zoetis Inc. ZTS

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows July 14)

• 4D Molecular Therapeutics, Inc. FDMT
• 89bio, Inc. ETNB
• AbCellera Biologics Inc. ABCL
• Achilles Therapeutics plc ACHL
• Adicet Bio, Inc. ACET
• Adverum Biotechnologies, Inc. ADVM
• Akero Therapeutics, Inc. AKRO
• Allena Pharmaceuticals, Inc. ALNA (announced a registered direct offering)
• Allogene Therapeutics, Inc. ALLO
• AlloVir, Inc. ALVR
• Aptose Biosciences Inc. APTO
• Avenue Therapeutics, Inc. ATXI
• Aytu Biopharma, Inc. AYTU
• Baudax Bio, Inc. BXRX
• BioXcel Therapeutics, Inc. BTAI
• Black Diamond Therapeutics, Inc. BDTX
• Bolt Biotherapeutics, Inc. BOLT
• Celyad Oncology SA CYAD
• Cerus Corporation CERS
• Checkmate Pharmaceuticals, Inc. CMPI
• Chembio Diagnostics, Inc. CEMI
• Cidara Therapeutics, Inc. CDTX
• Codex DNA, Inc. DNAY
• Concert Pharmaceuticals, Inc. CNCE
• Corvus Pharmaceuticals, Inc. CRVS
• Cue Biopharma, Inc. CUE
• CytomX Therapeutics, Inc. CTMX
• Design Therapeutics, Inc. DSGN
• Diffusion Pharmaceuticals Inc. DFFN
• DURECT Corporation DRRX
• ERYTECH Pharma S.A. ERYP
• Esperion Therapeutics, Inc. ESPR
• Exelixis, Inc. EXEL
• Foghorn Therapeutics Inc. FHTX
• Galapagos NV GLPG
• Galecto, Inc. GLTO
• Gemini Therapeutics, Inc. GMTX
• Genfit SA GNFT
• Gossamer Bio, Inc. GOSS
• HOOKIPA Pharma Inc. HOOK
• Ikena Oncology, Inc. IKNA
• IMARA Inc. IMRA (announced pricing of its common stock offering)
• InflaRx N.V. IFRX
• Inhibikase Therapeutics, Inc. IKT
• iRhythm Technologies, Inc. IRTC
• Kala Pharmaceuticals, Inc. KALA
• Kinnate Biopharma Inc. KNTE
• Kiromic BioPharma, Inc. KRBP
• LogicBio Therapeutics, Inc. LOGC
• Medicenna Therapeutics Corp. MDNA
• MediciNova, Inc. MNOV
• Mersana Therapeutics, Inc. MRSN
• Metacrine, Inc. MTCR
• Minerva Neurosciences, Inc. NERV
• Molecular Templates, Inc. MTEM
• MorphoSys AG MOR
• Nabriva Therapeutics plc NBRV
• Neoleukin Therapeutics, Inc. NLTX
• NeuBase Therapeutics, Inc. NBSE
• NexImmune, Inc. NEXI
• NextCure, Inc. NXTC
• NuCana plc NCNA
• Nymox Pharmaceutical Corporation NYMX
• OncoSec Medical Incorporated ONCS
• Orchard Therapeutics plc ORTX
• Otonomy, Inc. OTIC
• PolyPid Ltd. PYPD
• Praxis Precision Medicines, Inc. PRAX
• Protara Therapeutics, Inc. TARA
• Sarepta Therapeutics, Inc. SRPT
• Sensei Biotherapeutics, Inc. SNSE
• Sigilon Therapeutics, Inc. SGTX
• Silk Road Medical, Inc SILK
• Singular Genomics Systems, Inc. OMIC
• Syros Pharmaceuticals, Inc. SYRS
• Terns Pharmaceuticals, Inc. TERN
• Theravance Biopharma, Inc. TBPH
• TransCode Therapeutics, Inc. RNAZ (IPOed Friday)
• Travere Therapeutics, Inc. TVTX
• Unicycive Therapeutics, Inc. UNCY (IPOed Tuesday)
• Universe Pharmaceuticals INC UPC
• Vivos Therapeutics, Inc. VVOS
• Vor Biopharma Inc. VOR
• Voyager Therapeutics, Inc. VYGR

Stocks In Focus

Incyte Announces Publication Of Positive Late-Stage Data For Jakafi In Graft Vs. Host Disease

Incyte INCY announced positive data from the Phase 3 REACH3 study have been published in the New England Journal of Medicine, demonstrating that treatment with ruxolitinib resulted in significantly improved outcomes in patients with steroid-refractory or steroid-dependent chronic graft-versus-host disease compared to best available therapy.

The company also presented new subgroup analyses showing favorable overall response rate at week 24 for ruxolitinib across all major subgroups, including baseline individual organ involvement. REACH3 is jointly sponsored by Incyte and Novartis AG NVS.

Galapagos Reports Mixed Data From Study Of GLPG3970

Galapagos reported positive topline results with tyrosine kinase 2 inhibitor GLPG3667 in a Phase 1b study in psoriasis patients. GLPG3667 was well-tolerated in this trial. At week four, four out of 10 patients in the high dose group had a PASI 50 response, defined as at least a 50% improvement in PASI from baseline, compared to one out of 10 subjects on placebo. There were no subjects with a PASI 50 response on the low dose of GLPG3667.

Positive efficacy signals were also observed with the high dose for other endpoints, including affected Body Surface Area and physician and patient global assessment, versus placebo at week four.

Separately, Galapagos reported topline results with GLPG3970 in three patient studies. GLPG3970 did not show efficacy in a Phase 2a ulcerative colitis study and Phase 2a study in rheumatoid arthritis. However, it proved to be effective in a Phase 1b study in psoriasis.

The stock was down 11.5% at $58.23 in premarket trading,

J&J Recalls Sunscreen Products Due To The Presence Of Low Levels Of Benzene

Johnson & Johnson JNJ said it is voluntarily recalling all lots of five Neutrogena and Aveeno aerosol sunscreen product lines to the consumer level. Internal testing identified low levels of benzene in some samples of the products, it added.

The company issued an advisory that consumers should stop using the affected products.

The stock was down 0.54% at $169.50 in premarket trading.

Lipocine Announces Legal Settlement Agreement With Clarus

Lipocine Inc. LPCN announced a global settlement and license agreement with Clarus Therapeutics to resolve all outstanding claims in the ongoing intellectual property litigation between the two companies as well as the ongoing interference proceeding between the two companies.

The stock was up 7.75% at $1.39 in premarket trading.

Xoma Acquires Royalty Interest In Investigational Tumor Treatment

XOMA Corporation XOMA said it has acquired the royalty interest position Kuros Biosciences holds in Checkmate Pharmaceuticals' vidutolimod, an advanced-generation, Toll-like receptor 9 agonist packaged in a virus-like particle, for $7 million upfront plus sales milestones.

Vidutolimod is designed to trigger the body's innate immune system to attack tumors in combination with other therapies.

Related Link: The Week Ahead In Biotech: Adcom Test Awaits FibroGen, Data Readouts, IPOs In The Mix

MorphoSys Consummates Constellation Pharma Acquisition

MorphoSys announced the completion of its previously announced cash tender offer for all outstanding shares of Constellation Pharmaceuticals, Inc. CNST for $34 per share, net to the seller in cash, without interest and subject to any applicable withholding of taxes.

Approximately 42.81 million shares of Constellation were validly tendered, and not validly withdrawn in the tender offer, representing approximately 89% of Constellation's outstanding shares at the time of the expiration of the tender offer.

The merger is expected to close Thursday before the start of trading on the Nasdaq and Constellation shares will cease trading.

MorphoSys shares were down 6.62% at $16.92 in premarket trading.

Aeglea Announces Publication Of Positive Phase 1/2 Data

Aeglea BioTherapeutics, Inc. AGLE announced publication of positive 20-week data from the Phase 1/2 clinical trial of pegzilarginase for the treatment of arginase 1 deficiency, a rare, progressive disease characterized by high levels of the amino acid arginine.

Pegzilarginase is being evaluated in an ongoing Phase 3 pivotal trial for the treatment of ARG1-D.

TransMedics Gets AdCom Backing For OCS Liver System

TransMedics Group, Inc. TMDX announced that after review and discussion of its clinical evidence from the OCS Liver PROTECT trial, the Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee convened by the FDA has issued a favorable vote in support of approval of the OCS Liver System.

The stock was jumping 18.18% to $37.45 in premarket trading.

Offerings

Immunic, Inc. IMUX announced that it intends to offer and sell shares of its common stock in an underwritten public offering. All the shares to be sold will be offered by the company.

The stock was slipping 13.79% to $10.25 in premarket trading.

IMV Inc. IMV said it has filed a preliminary prospectus supplement for a proposed public offering of units. Each unit will be comprised of one common share and fixed combination of warrants to purchase common shares.

In premarket trading, the stock was plunging 14.9% to $1.77.

On The Radar

Adcom Calendar

FDA's Cardiovascular and Renal Drugs Advisory Committee is scheduled to meet Thursday to discuss the NDA for FibroGen, Inc.'s FGEN roxadustat for the treatment of anemia due to chronic kidney disease in adult patients not on dialysis and on dialysis. FibroGen is partnering with AstraZeneca for roxadustat. Roxadustat is already approved in Japan and China.

Earnings

Theratechnologies Inc. THTX (before the market open)

IPO

Salt Lake City, Utah-based Sera Prognostics, Inc. priced its initial public offering of 4.69 million shares of its Class A common stock at $16 per share compared to an estimated price range of $15-$17.

Sera is a women's health diagnostic company utilizing its proprietary proteomics and bioinformatics platform to discover clinically meaningful and economically impactful biomarker tests, with an initial focus on improving pregnancy outcomes. The shares will begin trading on the Nasdaq under the ticker symbol "SERA."

Sight Sciences, Inc., a medical device company that focuses on development of proprietary devices targeting the underlying causes of eye diseases, priced its upsized IPO of 10 million shares at $24 per share, above the estimated price range of $20-$23. The shares are expected to begin trading on the Nasdaq under the ticker symbol "SGHT."

Rapid Micro Biosystems, Inc, a life sciences technology company providing automation solutions to facilitate the efficient manufacturing and fast, safe release of healthcare products, priced its IPO of 7.92 million shares of its Class A common stock at $20 per share. All of the shares of Class A common stock are being offered by Rapid Micro. The gross proceeds from the offering are expected to be $158.4 million.

Rapid Micro's Class A common stock is expected to begin trading on the Nasdaq under the ticker symbol "RPID."

Related Link: Attention Biotech Investors: Mark Your Calendar For July PDUFA Dates