The Daily Biotech Pulse: GlaxoSmithKline, IDEAYA Strike Oncology Partnership, Decision Day For Merck, Adverum's New CEO

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 June 16)

• Applied Molecular Transport Inc AMTI (went public June 5)
• Avidity Biosciences Inc RNA (went public Friday)
• BioXcel Therapeutics Inc BTAI
• Brainstorm Cell Therapeutics Inc BCLI (announced granting of SME status by the European Medicines Agency that gives it significant financial incentives)
• Burning Rock Biotech Ltd BNR (went public Friday)
• Castle Biosciences Inc CSTL
• Celldex Therapeutics, Inc. CLDX
• Celsion Corporation CLSN
• Fennec Pharmaceuticals Inc FENC
• GENMAB A/S/S ADR GMAB
• Keros Therapeutics Inc KROS
• Momenta Pharmaceuticals, Inc. MNTA (announced positive top-line data from an interim analysis of midstage study results from nipocalimab in myasthenia gravis)
• Neubase Therapeutics Inc NBSE
• Nymox Pharmaceutical Corp NYMX
• Ocular Therapeutix Inc OCUL
• Passage Bio Inc PASG
• TELA Bio Inc TELA
• Vaxcyte Inc PCVX (went public Friday)

Down In The Dumps

(Biotech Stocks Hitting 52-week Lows June 16)

• CALLIDITAS THER/S ADR CALT (went public June 5)
• Evofem Biosciences Inc EVFM
• Sonnet Biotherapeutics Holdings Inc SONN

Stocks In Focus

Lily's Rapid-Acting Insulin Injection Gets FDA Nod; Biopharma Announces Positive Results For Breast Cancer Study

Eli Lilly And Co LLY said the FDA has approved Lyumjev (insulin lispro-aabc injection 100 units/mL and 200 units/mL), its new rapid-acting insulin indicated to improve glycemic control in adults with Type 1 and Type 2 diabetes. The company said the drug acts similar to how natural insulin works after meals in people without diabetes. The company also said it is working to make available Lyumjev to adults with diabetes in the U.S. as early as possible.

Separately, the company announced its Verzenio in combination with standard adjuvant endocrine therapy has met the primary endpoint of invasive disease-free survival, significantly decreasing the risk of breast cancer recurrence or death compared to standard adjuvant ET alone. The results are from a pre-planned interim analysis of the Phase 3 monarchE study.

The stock was up 8.54% at $153.60 premarket Tuesday.

Otonomy On Track For 3 Clinical Trial Readouts; Cash Adequate Through Mid-2021

In an update on its pipeline progress and liquidity in the wake of the COVID-19 pandemic, Otonomy Inc OTIC said it has clinical trial catalysts in the coming months for three novel product candidates:

• OTIVIDEX Phase 3 clinical trial in Ménière's disease in the first quarter of 2021
• Results from exploratory efficacy cohort from the Phase 1/2 clinical trial of OTO-313 in tinnitus due in July 2020
• Results from the Phase 1/2 study of OTO-413 in hearing loss due in the fourth quarter of 2020

The company maintained its 2020 GAAP operating expense guidance at $45 million to $48 million and non-GAAP operating expense guidance at $35 million to $38 million. The company also said it expects that its current cash, cash equivalents, and short-term investments will be sufficient to fund company operations through mid-2021. 

The stock was up 6.16% at $3.10. 

GlaxoSmithKline Announces Strategic Partnership With IDEAYA In Synthetic Lethality

GlaxoSmithKline plc GSK and Ideaya Biosciences Inc IDYA announced a strategic partnership in synthetic lethality, an emerging field in oncology, which included the latter's synthetic lethality programs MAT2A, Pol Theta and Werner Helicase. Both these programs are to reach clinical trials within the next three years, the companies said.

According to the agreement, IDEAYA is to lead the MAT2A program through early clinical development and meet all costs before GlaxoSmithKline exercises options. Thereafter, IDEAYA will contribute 20% of the global development costs. In return, IDEAYA will receive a 50% U.S. profit share and ex-U.S. royalties for the MAT2A and Werner Helicase programs.

In premarket trading Tuesday, GlaxoSmithKline shares were rising 1.69% to $41.41 and IDEAYA was rallying 101.12% to $18.

See also: The Week Ahead In Biotech: FDA Decisions In The Cards For Merck, Epizyme, Evoke And Ultragenyx

Adverum Appoints Laurent Fischer As CEO

Gene therapy company Adverum Biotechnologies Inc ADVM announced the appointment of Laurent Fischer as the CEO and a member of the board. Leone Patterson, who most recently served as the company's CEO, will continue to serve as president.

In after-hours trading, the stock gained 4.89% to $24.86.

Addex's Out-Licensed Epilepsy Drug Moves Into Phase 2a Proof-Of-Concept Study

ADDEX THERAPEUT/ADR ADXN said JNJ-40411813, previously known as ADX71149, will advance into a Phase 2a proof-of-concept study in patients with epilepsy.

The multi-center study is scheduled to begin dosing patients in the U.S. in early 2021. Johnson & Johnson JNJ unit Janssen is responsible for the clinical development and commercialization of JNJ-40411813 under the terms of a licensing agreement with Addex.

Offerings

Celldex said it has priced its secondary offering 13.38 million shares of its common stock at $9.75 per share to generate gross proceeds of $130.4 million. The offering is expected to close June 18.

Constellation Pharmaceuticals Inc CNST said it has commenced an underwritten public offering of 4 million shares of its common stock. All of the shares are being offered by the company.

The stock was down 1.91% at $37 premarket Tuesday.

Oncolytics Biotech, Inc. ONCY said it has entered into an at-the-market equity offering sales agreement with Canaccord Genuity that will allow Oncolytics to issue common shares from treasury at prevailing market prices with an aggregate gross sales amount of up to $40 million over the course of the next 25 months.

On The Radar

PDUFA Dates

The FDA is scheduled to give its verdict on Merck & Co., Inc.'s MRK Keytruda as a monotherapy option for unresectable or metastatic solid tumors, with tissue tumor mutational burden-high.

Clinical Readouts/Presentations

Sanofi SA SNY is scheduled to host a virtual scientific session to present data from the Phase 3 COMET trial of investigational enzyme replacement therapy avalglucosidase alfa in patients with late-onset Pompe disease.

Related Link: Sinovac Makes Headway In Coronavirus Vaccine Race With Positive Preliminary Phase 1/2 Results