This week, the biotech sector witnessed numerous companies reassessing their project pipelines and trimming their workforce to conserve cash and extend their financial runways. Amidst these market adjustments, the regulatory environment showed positive movement with new drug approvals and expanded indications. Siga Technologies, however, faced a setback as its monkeypox (Mpox) vaccine candidate did not meet expectations in a clinical trial, although the company remains optimistic about the treatment’s future prospects.
Here are the details:
### Layoffs
**Viracta Therapeutics Inc. (VIRX)**
Viracta Therapeutics announced a 23% workforce reduction on Wednesday as part of its pipeline reprioritization. The company has decided to pause its EBV+ solid tumor program to concentrate on the more advanced EBV+ lymphoma program. The lead drug candidate, Nana-val, is currently in a phase II trial for relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) lymphoma, known as NAVAL-1. Preliminary data from the NAVAL-1 trial indicates significant antitumor activity and a generally favorable safety profile for Nana-val.
VIRX shares closed at $0.30 on Friday, down 11.76%.
**Lykos Therapeutics**
Following the FDA’s rejection of its MDMA-assisted therapy for PTSD earlier this month, Lykos Therapeutics announced on Thursday that it would lay off about 75% of its workforce. Despite this, the company will continue clinical research to address the FDA’s concerns.
**Galera Therapeutics Inc. (GRTX)**
Galera Therapeutics disclosed on Wednesday that its Board of Directors has approved a liquidation and dissolution plan to wind down its operations. This plan will be put to a vote at a special stockholders' meeting scheduled for around October 17, 2024. If not approved, the company will seek other strategic alternatives.
GRTX shares closed at $0.07 on Friday, up 3.91%.
**Acelyrin Inc. (SLRN)**
Acelyrin announced on Tuesday that it would reduce its workforce by approximately 40 employees, about one-third of its current headcount, as part of a restructuring initiative. The company has decided to suspend new internal investments in the development of its investigational drug Izokibep for hidradenitis suppurativa, psoriatic arthritis, and axial spondyloarthritis. Instead, it will focus on advancing its other investigational drug, Lonigutamab, specifically for thyroid eye disease (TED). The phase I proof-of-concept portion of the ongoing Lonigutamab trial has been completed, and the dose-ranging phase II portion in TED patients is continuing.
SLRN shares closed at $4.13 on Friday, up 3.77%.
**Lexicon Pharmaceuticals, Inc. (LXRX)**
On Tuesday, Lexicon Pharmaceuticals announced plans to cut more than 75 jobs or approximately 50% of its current field force by the end of Q3 2024. This strategic move follows a review of the company’s commercial and pipeline programs. Resources will now be reallocated to focus on promotional efforts for INPEFA in heart failure and the potential commercial launch of ZYNQUISTA for glycemic control in adults with type 1 diabetes and chronic kidney disease. These changes are expected to reduce operating costs by $40 million.
LXRX shares closed at $1.66 on Friday, up 1.22%.
**Boundless Bio Inc. (BOLD)**
Boundless Bio, an oncology-focused company, announced on Monday that it would scale back its early discovery efforts and implement modest workforce reductions to extend its operating runway. The exact number of affected employees was not disclosed. The company’s shares debuted on the Nasdaq Global Select Market at $16 per share as recently as March 28, 2024, and it held cash and short-term investments totaling $179.3 million as of June 30, 2024.
BOLD shares closed at $3.31 on Friday, down 0.90%.
**GRAIL Inc. (GRAL)**
GRAIL Inc. announced restructuring plans on Wednesday, which include reducing both existing headcount and planned hires for 2024 by 30%. These cost-cutting measures are expected to extend the company’s cash runway from the second half of 2026 into 2028. GRAIL completed its separation from Illumina (ILMN) on June 24, 2024.
GRAL shares closed at $16.75 on Friday, up 5.55%.### Ovid Therapeutics Inc. Announces Workforce Reduction
Ovid Therapeutics Inc. (NASDAQ: OVID) announced on Tuesday that it would be reducing 17 positions, which represents 43% of its workforce, in an effort to focus on its core programs and prolong its cash runway. The company expects to incur $3.4 million in cash expenditures related to the restructuring. As part of this strategic realignment, Ovid will concentrate its resources on advancing its OV888/GV101 and OV329 oral programs towards significant clinical milestones, while suspending the intravenous (IV) OV329 program and other preclinical initiatives. The OV888/GV101 program is currently in a phase II proof-of-concept study for cerebral cavernous malformations. OV329, which is being developed as a potential treatment for rare and treatment-resistant forms of epilepsy and seizures, is in phase I development.
Ovid's stock closed at $1.13 on Friday.
### FDA Approvals
**AstraZeneca PLC (NASDAQ: AZN)**
AstraZeneca's cancer drug Imfinzi received FDA approval on Friday for use in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy post-surgery for resectable early-stage (IIA-IIIB) non-small cell lung cancer without known EGFR mutations or ALK rearrangements. In clinical trials, the Imfinzi-based regimen reduced the risk of recurrence, progression, or death by 32% compared to neoadjuvant chemotherapy alone in patients with resectable Stage IIA-IIIB non-small cell lung cancer, regardless of PD-L1 expression. Imfinzi is also approved for treating Small Cell Lung Cancer, Biliary Tract Tumor, Hepatocellular Carcinoma, and Endometrial Cancer. The drug generated $2.259 billion in sales for the first half of 2024, up from $1.976 billion during the same period the previous year.
AstraZeneca's stock closed at $84.41 on Friday, down 0.58%.
**Gilead Sciences Inc. (NASDAQ: GILD)**
Gilead Sciences announced on Wednesday that the FDA granted accelerated approval for Livdelzi for the treatment of primary biliary cholangitis, a rare liver disease. Livdelzi is indicated for use in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients intolerant of UDCA. Livdelzi was acquired through Gilead's acquisition of CymaBay Therapeutics for $4.3 billion in February 2023.
Gilead's stock closed at $73.78 on Friday, down 0.75%.
**Incyte and Syndax Pharmaceuticals (NASDAQ: INCY and NASDAQ: SNDX)**
The FDA approved Niktimvo for treating chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg. Niktimvo, Incyte’s second approved treatment for chronic GVHD, will be co-commercialized by Incyte and Syndax in the U.S., with Incyte holding exclusive commercialization rights outside the U.S. Niktimvo is anticipated to launch in the U.S. by early Q1 2025.
Incyte’s stock closed at $62.16 on Friday, up 0.78%.
**Galderma**
On Tuesday, Galderma received FDA approval for Nemluvio as a pre-filled pen for subcutaneous injection in treating prurigo nodularis, a neuroimmune skin disease that affects up to 181,000 people in the U.S. Galderma has also applied for FDA approval of Nemluvio for treating moderate-to-severe atopic dermatitis, with a decision expected later this year.
**Ascendis Pharma A/S (NASDAQ: ASND)**
Ascendis Pharma secured FDA approval for Yorvipath for treating hypoparathyroidism in adults, a rare endocrine disease affecting 70,000 to 90,000 individuals in the U.S. Yorvipath, approved in Europe last December, is the first and only treatment for this condition.
Ascendis Pharma’s stock closed at $138.84 on Friday, down 0.47%.
### Deal or No Deal
**Revance Therapeutics Inc. (NASDAQ: RVNC)**
Revance Therapeutics, the maker of the anti-wrinkle drug Daxxify, agreed on Monday to be acquired by Crown Laboratories Inc. for $924 million, or $6.66 per share in cash. The deal is expected to close by the end of 2024. Revance is embroiled in a trade secret dispute with Allergan, a subsidiary of AbbVie Inc. (NYSE: ABBV), which accuses Revance of misappropriating trade secrets and poaching multiple Allergan employees with access to proprietary information.
Revance’s stock closed at $6.62 on Friday, up 0.46%.AnaptysBio Inc. (ANAB), a clinical-stage biotechnology firm, announced on Wednesday the pricing of an underwritten offering of 2.75 million shares of its common stock at $36.50 per share. The transaction was spearheaded by long-term investor EcoR1 Capital, with participation from both existing and new investors, including Sanofi (SNY). The offering is anticipated to generate approximately $100 million in gross proceeds. The company is currently conducting a Phase IIb trial of its drug candidate ANB032 for the treatment of atopic dermatitis, with topline results expected in December.
In the latest trading session on Friday, ANAB stock closed at $34, marking a 4.78% increase.
### Clinical Trials - Breakthroughs & Setbacks
Incyte (INCY) reported on Thursday positive results from its pivotal Phase III trial of Monjuvi, combined with lenalidomide and rituximab, in patients with relapsed or refractory follicular lymphoma. The trial, known as MIND, successfully met its primary endpoint of progression-free survival. Incyte plans to submit a supplemental Biologics License Application for Monjuvi by the end of the year for patients with follicular lymphoma who have failed at least one prior systemic anti-CD20 immunotherapy or chemo-immunotherapy. Monjuvi is already FDA-approved in combination with lenalidomide for relapsed or refractory diffuse large B-cell lymphoma. In the second quarter of 2024, global sales of Monjuvi reached $31 million, compared to $13 million in the same period last year.
INCY stock closed Friday's session at $62.16, up 0.78%.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), released on Thursday the underwhelming results from the PALM 007 study evaluating SIGA Technologies Inc.'s (SIGA) Tecovirimat for the treatment of monkeypox (mpox) in the Democratic Republic of the Congo. The preliminary analysis indicated that the study failed to achieve statistical significance in its primary endpoint of Tecovirimat being superior to a placebo in lesion resolution across all patients. Nonetheless, significant improvement was observed in patients treated with Tecovirimat whose symptoms began within seven days before randomization and in those with severe disease (defined by the World Health Organization as having 100 or more skin lesions). Tecovirimat, known in the U.S. and Canada as TPOXX, is approved for the treatment of smallpox and has authorization in Europe and the UK for treating smallpox, mpox (monkeypox), cowpox, and vaccinia complications.
SIGA saw its shares rise 9.04%, closing Friday’s trading at $10.49.
Pfizer Inc. (PFE) and BioNTech SE (BNTX) disclosed mixed results on Friday from a Phase III trial of their mRNA-based combination vaccine against influenza and COVID-19 for individuals aged 18-64. While the combination vaccine showed higher immune responses against influenza A when compared to a licensed influenza vaccine, it demonstrated lower geometric mean titers (GMT) and seroconversion rates for the influenza B strain. The vaccine candidate also exhibited comparable responses to SARS-CoV-2 when compared to the companies' licensed COVID-19 vaccine, Comirnaty.
PFE shares closed Friday’s trading at $28.30, down 1.43%.
