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)

Down In The Dumps

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

Stocks In Focus

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

Aprea Therapeutics, Inc. (NASDAQ: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

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. (NASDAQ: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

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

Related Link: The Week Ahead In Biotech (Sept. 19-25): Incyte, Verrica FDA Decisions And Conference Presentations In The Spotlight

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

Aerie Pharmaceuticals, Inc. (NASDAQ: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

"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 (NYSE: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 (NASDAQ: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. (NASDAQ: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. (NASDAQ: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

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.

Click here to access Benzinga's FDA Calendar.

On The Radar

PDUFA Dates

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

Clinical Readouts/Presentations

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