The Daily Biotech Pulse: Aprea Jumps On ESMO Presentation, Verrica Sinks On Regulatory Setback, Aerie CEO Quits, J&J Touts Positive COVID-19 Booster Shot Data - Absci (NASDAQ:ABSI), Aditxt (NASDAQ:ADTX)

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 Sept. 20)

Cerevel Therapeutics Holdings, Inc. CERE
Corvus Pharmaceuticals, Inc. NASDAQ: CRVS) (move attributed to short squeeze)
Edesa Biotech, Inc. EDSA (announced positive Phase 2 data for monoclonal antibody in hospitalized COVID-19 patients)
Entasis Therapeutics Holdings Inc. ETTX
Fulcrum Therapeutics, Inc. FULC
Opiant Pharmaceuticals, Inc. OPNT
Repligen Corporation RGEN

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows Sept. 20)

Ambrx Biopharma Inc. AMAM
4D pharma plc LBPS
Absci Corporation ABSI
Acutus Medical, Inc. AFIB
Aditxt, Inc. ADTX
Alzamend Neuro, Inc. ALZN
Applied Therapeutics, Inc. APLT
Assertio Holdings, Inc. ASRT
Avenue Therapeutics, Inc. ATXI
Aytu Biopharma, Inc. AYTU
AzurRx BioPharma, Inc. AZRX
Biophytis SA BPTS
Centessa Pharmaceuticals Limited CNTA
Codex DNA, Inc. DNAY
CVRx, Inc. CVRX
Dermata Therapeutics, Inc. DRMA
Eiger BioPharmaceuticals, Inc. EIGR (DSMB recommended continuation of dosing of peginterferon lambda in Phase 3 COVID-19 study)
Elevation Oncology, Inc. ELEV
FibroGen, Inc. FGEN
Forte Biosciences, Inc. FBRX
Forward Pharma A/S FWP
Gain Therapeutics, Inc. GANX
Galapagos NV GLPG
HCW Biologics Inc. HCWB
InMed Pharmaceuticals Inc. INM
Inozyme Pharma, Inc. INZY
Keros Therapeutics, Inc. KROS
Lixte Biotechnology Holdings, Inc. LIXT
Lyell Immunopharma, Inc. LYEL
Madrigal Pharmaceuticals, Inc. MDGL
Mesoblast Limited MESO
Miromatrix Medical Inc. MIRO
NeuroPace, Inc. NPCE
Oncorus, Inc. ONCR
Oyster Point Pharma, Inc. OYST
Pasithea Therapeutics Corp. KTTA (IPOed Wednesday)
Pharming Group N.V. PHAR
Pliant Therapeutics, Inc. PLRX
Poseida Therapeutics, Inc. PSTX
Protagonist Therapeutics, Inc. PTGX
Rain Therapeutics Inc. RAIN
Rallybio Corporation RLYB
RedHill Biopharma Ltd. RDHL
Sera Prognostics, Inc. SERA
Sight Sciences, Inc. SGHT
Singular Genomics Systems, Inc. OMIC
Sonoma Pharmaceuticals, Inc. SNOA
Spruce Biosciences, Inc. SPRB
Talis Biomedical Corporation TLIS
TCR2 Therapeutics Inc. TCRR
Teligent, Inc. TLGT
TherapeuticsMD, Inc. TXMD
Titan Pharmaceuticals, Inc. TTNP
TransCode Therapeutics, Inc. RNAZ
Trevi Therapeutics, Inc. TRVI
TScan Therapeutics, Inc. TCRX
Tyra Biosciences, Inc. TYRA (IPOed Wednesday)
XBiotech Inc. XBIT

Stocks In Focus

Aprea Reports Positive Phase 1/2 Study of Eprenetapopt In Solid Tumors

Aprea Therapeutics, Inc. APRE announced at the European Society of Medical Oncology Congress results from the Phase 1/2 study of eprenetapopt in solid tumors. In the bladder/urothelial cohort, one patient with locally advanced TP53 mutant high-grade transitional cell bladder cancer had achieved complete remission by RECIST criteria at the first response assessment at nine weeks.

In the non-small cell lung cancer cohort, two patients with TP53 mutant squamous NSCLC had reductions in target lesions of 26.7% and 8.2%, respectively, from baseline by RECIST criteria at the first response assessment at nine weeks. Adverse events, regardless of causality, were mostly grade 1/2.

The stock was climbing 15.46% to $5.46 in premarket trading.

Seagen, Genmab Announce FDA Accelerated Approval For Antibody-Drug Conjugate In Cervical Cancer

Genmab A/S GMAB and Seagen Inc. SGEN announced the Food and Drug Administration has granted accelerated approval to Tivdak, the first and only approved antibody-drug conjugate for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

Tivdak was approved under the FDA's "Accelerated Approval Program" based on tumor response and the durability of the response. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

Genmab was seen gaining 2.47% to $44 in premarket trading.

Verrica's Regulatory Application For Viral Skin Disease Treatment Shot Down With Complete Response Letter

Verrica Pharmaceuticals Inc. VRCA said the FDA has issued a complete response letter regarding its new drug application for VP-102 for the treatment of molluscum contagiosum.

The FDA has identified deficiencies at a facility of a contract manufacturing organization, which are not specifically related to the manufacturing of VP-102 but instead raise general quality issues at the facility. The regulator, however, did not identify any clinical, safety or product specific chemistry, manufacturing and controls deficiencies related to VP-102.

The stock was plunging 29.34% to $8.50 in premarket trading.

Amgen Gets Favorable Ruling In Litigation Over Psoriasis Therapy Patents

Amgen, Inc. AMGN announced the U.S. District Court for the District of New Jersey has upheld patents that protect Amgen's psoriasis therapy Otezla in a patent infringement lawsuit against Novartis AG NVS's Sandoz Inc. and Zydus Pharmaceuticals.

The asserted a patents claim to apremilast as a composition of matter, methods of treating psoriasis with apremilast and crystalline forms of apremilast. The court found infringement and upheld the validity of four patents — three against each defendant — but ruled against Amgen on claims in the patent covering methods of treating psoriasis with apremilast according to a specific dosing schedule.

The decision will prevent Sandoz and Zydus from making, using, selling, offering to sell or importing each of their generic versions of Otezla until expiration of the COM patent in February 2028.

Amgen shares were edging up 0.2% at $215.55 in premarket trading

Aerie's Chairman, CEO Departs; Biopharma Names Interim Executive Chairman

Aerie Pharmaceuticals, Inc. AERI said long-serving chairman and CEO Vicente Anido has departed effective Sept. 17.

Consistent with the succession plan in place, the company's board has appointed Benjamin McGraw III as its interim executive chairman of board. The company also said it has commenced a search for a new CEO.

Upon the appointment of a new CEO, the company intends to separate the roles of chairman and CEO.

The stock was down 1.55% at $11.41 in premarket trading.

J&J Announces New Positive Data For Single-Shot COVID-19 Vaccine

Johnson & Johnson JNJ announced new data reinforcing the strong and long-lasting protection of its COVID-19 vaccine. New data also showed that protection against COVID-19 increases when a booster shot of the Johnson & Johnson vaccine is administered. The safety profile of the vaccine remained consistent and was generally well-tolerated when administered as a booster.

"Our single-shot vaccine generates strong immune responses and long-lasting immune memory. And, when a booster of the Johnson & Johnson COVID-19 vaccine is given, the strength of protection against COVID-19 further increases," said Mathai Mammen, global head, Janssen R&D.

The stock was up 1.04% at $165.51 in premarket trading.

Boston Scientific To Acquire Devoro Medical For About $336M

Boston Scientific Corporation BSX announced an agreement to acquire Devoro Medical, Inc., developer of the WOLF Thrombectomy Platform. The innovative non-console and lytic-free WOLF technology targets and rapidly captures blood clots using finger-like prongs that retrieve and remove thrombi in the arterial and venous systems.

Boston Scientific has been a strategic investor in Devoro Medical since 2019 and holds an equity stake of approximately 16%. As a result, the transaction consists of an upfront payment of approximately $269 million for the 84% stake not yet owned and up to $67 million upon achievement of certain clinical and regulatory milestones.

Immuneering Added To Russell 2000 Index

Immuneering Corporation IMRX, a biopharma focusing on therapies for oncology and neurosciences, said it has been selected to be added to the Russell 2000 Index effective Sept. 20 after the close of the U.S. equity markets.

Lucira Appoints Tony Allen As Chief Operations Officer

Lucira Health, Inc. LHDX announced operations expert Tony Allen has joined the company as chief operations officer.

"Tony has a stellar track record in operations management. We're delighted that he's bringing his experience, skill set, and high energy level to Lucira as we continue expanding production and the capabilities of our unique test for COVID-19 and then other pathogens," said CEO Erik Engelson.

Stoke Announces Positive Early Stage Data On STK-001 In Dravet Syndrome

Stoke Therapeutics, Inc. STOK announced positive safety, pharmacokinetic and cerebrospinal fluid exposure data from a planned interim analysis of the Phase 1/2a MONARCH study of STK-001 in children and adolescents with Dravet syndrome. STK-001 is an investigational new medicine for the treatment of Dravet syndrome.

Offerings

Viridian Therapeutics, Inc. VRDN said it is selling a total of 6.19 million shares of common stock at a public offering price of $11 per share and 23,126 shares of Series B preferred stock at a public offering price of $733.37 per share, which is convertible into approximately 1.54 million shares of common stock, subject to beneficial ownership conversion limits.

The company expects to raise gross proceeds of about $85 million from the offering.

The stock was soaring 41.72% at $15.15 in premarket trading.

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On The Radar

PDUFA Dates

The FDA is scheduled to announce its verdict on Incyte Corporation INCY's new drug application for ruxolitinib cream in atopic dermatitis.

Clinical Readouts/Presentations

PTC Therapeutics, Inc. PTCT is scheduled to host a conference call at 8 a.m. to discuss positive results from the PTC518 Phase 1 Huntington's disease healthy volunteer study. The new results include HTT mRNA and protein lowering, as well as PTC518 exposure levels in the cerebrospinal fluid, consistent with the compound penetrating the blood-brain barrier and not being effluxed out of the brain.

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