Biotech Stock Roundup: VNDA, JAZZ Up on Updates, NVAX Suffers Setback & More

Last week, the biotech sector was in focus, with regular pipeline and regulatory updates. Vanda Pharmaceuticals Inc. VNDA was in the spotlight after it rejected a second takeover bid by Cycle Group.

Here's a recap of the week’s most important stories:

EXEL Up on Patent Ruling

Exelixis, Inc. EXEL announced that the District Court of Delaware has ruled in its favor in the second patent litigation against MSN Laboratories. EXEL has been involved in a lawsuit with MSN since 2019, when the latter submitted an abbreviated new drug application (ANDA) to the FDA requesting approval to market a generic version of the former’s lead drug Cabometyx (cabozantinib) tablets.

The Delaware District Court ruled in Exelixis’ favor, rejecting MSN’s challenge to three Orange Book-listed patents related to cabozantinib, including U.S. Patents No. 11,091,439 (crystalline salt), 11,091,440 (pharmaceutical compositions) and 11,098,015 (methods of treatment). The court also ruled that Exelixis’ pharmaceutical composition patent (U.S. 11,298,349) is not invalid or infringed by MSN’s proposed ANDA product.

MSN is seeking approval for a product containing a different polymorphic form of cabozantinib (l)-malate than the form included in Cabometyx. Exelixis added that the FDA has not yet granted tentative approval for the potential product. If the FDA ultimately approves MSN’s ANDA, the earliest that it may be permitted to commercially launch its proposed generic product in the United States is January 2030, subject to any appeal or additional regulatory exclusivity.

Earlier, Exelixis entered into a clinical development collaboration agreement with pharma giant Merck MRK to advance the development of its pipeline candidate, zanzalintinib.

Exelixis will evaluate zanzalintinib in combination with Merck’s blockbuster anti-PD-1 therapy Keytruda (pembrolizumab) in a late-stage study for treating patients with head and neck squamous cell carcinoma.

Both the companies will also evaluate zanzalintinib with Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor Welireg (belzutifan) in a phase I/II study and two phase III studies for the treatment of patients with renal cell carcinoma (RCC).

Per the terms of the agreement, Merck will supply Keytruda for the ongoing, Exelixis-sponsored phase III STELLAR-305 study in previously untreated PD-L1 positive recurrent or metastatic HNSCC.

Additionally, Merck will sponsor a phase I/II trial and two phase III studies in RCC. While Merck will fund one of these phase III studies, Exelixis will co-fund the phase I/II study and the other phase III study, as well as supply zanzalintinib and cabozantinib.

Exelixis currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

VNDA Up on Takeover Rejection

Vanda Pharmaceuticals announced that its board of directors has unanimously rejected a second acquisition bid by Cycle Group Holdings Ltd., wherein the latter proposed to acquire VNDA for $8.00 per share in cash.

The second takeover proposal from Cycle Group was received on Sept. 23, 2024. Per management, the second unsolicited, non-binding acquisition proposal was economically identical to Cycle Group's previous takeover interest received by the company in May.

After thoroughly reviewing the second takeover bid, Vanda’s board of directors concluded that the latest proposal substantially undervalues the company and is not in the best interests of the company and its shareholders. Vanda shareholders will not have to take any immediate action related to the second unsolicited takeover proposal from the Cycle Group.

The stock gained on the news.

JAZZ Up on Study Results

Jazz Pharmaceuticals JAZZ announced positive top-line results from the phase III IMforte study, which evaluated Zepzelca (lurbinectedin), combined with PD-L1 inhibitor Tecentriq (atezolizumab), in patients with extensive-stage small cell lung cancer (ES-SCLC) following induction therapy with carboplatin, etoposide and atezolizumab.

Results showed that the combo treatment of Zepzelca and Tecentriq resulted in a statistically significant improvement in the primary endpoints of overall survival and progression-free survival compared to standalone Tecentriq treatment. The combination therapy was also well-tolerated in study participants, with no new safety signal.

Based on the above results, Jazz intends to submit a regulatory filing in first-half 2025 seeking approval for Zepzelca plus Tecentriq as a first-line maintenance treatment for ES-SCLC. It also plans to present the IMforte results at a future medical meeting. The stock gained on the news.

Jazz’s Zepzelca has been approved by the FDA under the accelerated pathway since 2020 to treat adult patients with metastatic small-cell lung cancer who have already been treated with platinum-based chemotherapy.

Setback for NVAX

Novavax NVAX suffered a setback when the FDA placed a clinical hold on its investigational new drug (IND) application for its COVID-19-Influenza combination and stand-alone influenza vaccine candidates.  The stock was down following the announcement.

The hold was placed due to a spontaneous report of a serious adverse event (SAE) of motor neuropathy in a single CIC phase II study participant outside the United States, who received the vaccine in January 2023. The SAE was reported in September 2024, while the study was completed in July 2023.

NVAX added that data from previous COVID-19 and influenza studies have shown no signal for motor neuropathy. The clinical hold does not impact the IND for Novavax's COVID-19 vaccine.

Performance

The Nasdaq Biotechnology Index has gained 3.47% in the past five trading sessions and Vertex shares have gained 4.12%. In the past six months, shares of MRNA have gained 44.64%. (See the last biotech stock roundup here: Biotech Stock Roundup: BHVN, WVE, ZVRA Stocks Up on Updates, BIIB & UCB’s Study Data & More)

Image Source: Zacks Investment Research

What's Next in Biotech?

Stay tuned for more pipeline updates.



 

Only $1 to See All Zacks' Buys and Sells

We're not kidding.

Several years ago, we shocked our members by offering them 30-day access to all our picks for the total sum of only $1. No obligation to spend another cent.

Thousands have taken advantage of this opportunity. Thousands did not - they thought there must be a catch. Yes, we do have a reason. We want you to get acquainted with our portfolio services like Surprise Trader, Stocks Under $10, Technology Innovators,and more, that closed 228 positions with double- and triple-digit gains in 2023 alone.

See Stocks Now >>

Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report

 
Exelixis, Inc. (EXEL): Free Stock Analysis Report
 
Jazz Pharmaceuticals PLC (JAZZ): Free Stock Analysis Report
 
Novavax, Inc. (NVAX): Free Stock Analysis Report
 
Vanda Pharmaceuticals Inc. (VNDA): Free Stock Analysis Report

To read this article on Zacks.com click here.

Zacks Investment Research