Gilead won't pursue U.S. approval for rheumatoid arthritis drug

 Gilead Sciences Inc said on Tuesday it had decided not to pursue the U.S. Food and Drug Administration's approval for its experimental rheumatoid arthritis treatment, filgotinib, following a meeting with the health regulator.

The FDA in August declined to approve the drug for rheumatoid arthritis after weighing the overall benefit of the 200 mg dose of the treatment against its risk profile.

Gilead said it had concluded that the 200 mg dose of the drug was unlikely to receive a U.S. approval without conducting additional clinical studies.

Last year, Gilead invested $5.1 billion in a major expansion of its partnership with Belgo-Dutch biotech Galapagos NV , banking on the potential of filgotinib and other drugs in development.

The two companies have now amended the pact, with Galapagos assuming sole responsibility in Europe for the drug, where it has been approved for treating moderate to severe forms of rheumatoid arthritis.

Galapagos will also assume all rights for filgotinib in Europe, with Gilead agreeing to pay 160 million euros ($194.43 million) to the company, they said in a joint statement.

Gilead and Galapagos said they no longer believe it was feasible to continue the current clinical trials of filgotinib for psoriatic arthritis, ankylosing spondylitis and non-infectious uveitis. ($1 = 0.8229 euros)

https://www.marketscreener.com/quote/stock/GILEAD-SCIENCES-INC-4876/news/Gilead-Sciences-says-not-to-pursue-U-S-approval-for-rheumatoid-arthritis-drug-32020531/

Prevail Ablaze On Eli Lilly's $1.04 Billion Takeover

 Eli Lilly (LLY) agreed to buy gene therapy company Prevail Therapeutics (PRVL) for $1.04 billion on Tuesday, sending PRVL stock to a record high.

The deal "checks the boxes" for Lilly, Mizuho Securities analyst Vamil Divan said in a report to clients. He noted that Lilly Chief Financial Officer Joshua Smiley has said in the past that the drug giant was looking to acquire a gene therapy player in the neuroscience space. Prevail's lead programs are in Parkinson's disease and dementia.

Lilly will pay $880 million upfront, valuing PRVL stock at $22.50 per share. Shareholders will also receive a contingent value right, or CVR, worth up to $4 per share for a total of $160 million. The CVR is payable when the first Prevail product gains regulatory approval.

On today's stock market, PRVL stock charged up 82% to 22.75. Lilly stock popped 6% to 167.43.

Piper Sandler analyst Christopher Raymond downgraded PRVL stock to a neutral rating on the takeover news. The deal is "not so surprising in retrospect," he said in his note to clients.

"With neuro a core therapeutic area for Lilly and with management commentary foreshadowing interest in gene therapy partnerships and acquisitions as recently as September, this move makes sense and we expect the deal to close on time in the first quarter," he said.

The news is also likely to spark other gene therapy stocks, not just PRVL stock, he said. To that point, shares of Uniqure (QURE) lifted 3.1% to 47.86.

"While there had been a spate of gene therapy deals, the last year has seen the space take a bit of a pause coincident with some gene therapy setbacks," he said. "Today's news indicates that strategic interest in the technology has not waned."

https://www.investors.com/news/technology/prvl-stock-eli-lilly-announces-takeover-deal/

Novavax in 2021

 If you thought the market was crazy about vaccine stocks this year, just wait until 2021. As coronavirus vaccines are distributed to the public and a slew of companies prepare to report new revenue from sales, 2020's winners could go big yet again.

Novavax (NASDAQ:NVAX) is one such stock. The company has gained about 3,130% year to date. It probably won't grow by that much next year, but that doesn't mean new investors are too late to enjoy significant gains. In my view, there are four solid reasons why Novavax will be worth a buy next year.

NVAX DATA BY YCHARTS

1. We'll get key efficacy data about NVX-CoV2373 soon

Novavax's coronavirus vaccine candidate is the project that put the company on the map. The company is on the verge of initiating phase 3 clinical trials of NVX-CoV2373 in the U.S. and Mexico, and its U.K.-based phase 3 trial just completed its enrollment. The U.K. trial could deliver preliminary results as early as the first quarter of next year. If the vaccine candidate is shown to be effective and safe, it'll boost the market's appraisal of the stock enormously, not to mention its revenue once it's commercialized. Currently, Novavax's trailing revenue is just over $204 million, none of which is from recurring sales. Investors may want to wait for the study's interim data readout before buying shares, just to be safe.

2. NanoFlu inches closer to approval

In March, the company successfully concluded its phase 3 clinical trials of the NanoFlu vaccine for seasonal influenza in older adults. That vaccine candidate was effective than Fluzone, the current leading product in that indication. The company still has some work to do, though. Specifically, it needs to manufacture enough doses to perform a lot-to-lot consistency trial so that regulators can confirm that the product is uniform. Once that's done, it'll be able to submit the product to the FDA for final approval.

Assuming that NanoFlu gets a green light from the regulator, it will be Novavax's first source of recurring revenue, and its stock price should jump as a result.

3. The Matrix-M adjuvant

Manufacturing the active ingredients of vaccines can be expensive. Plus, sometimes vaccines alone don't give the immune system enough of a boost to confer protection against a disease.

Both of those issues can be addressed by the use of adjuvants -- additives that increase a vaccine's effectiveness by stimulating a stronger, more durable immune response.

Novavax's adjuvant is called Matrix-M, and it's a critical component in both its coronavirus vaccine and NanoFlu. In both contexts, it should increase the competitiveness of the products from an economic perspective. With Matrix-M in the mix, each dose can use a smaller quantity of the actual vaccine, cutting overall manufacturing costs and increasing the number of doses that can be produced. For mass-scale immunizations like the one that will be required to end the current pandemic, those are especially useful features..

4. Profits may be right around the corner

It's entirely possible that both NanoFlu and NVX-CoV2373 will be approved for sale in 2021. While neither result is guaranteed, if they do reach the market, Novavax will be rolling in revenue to a degree it has never experienced before. Thanks in part to the U.S. government funding its coronavirus project to the tune of $1.6 billion, its profit-making potential is quite high.  

Novavax's valuation has ballooned since the start of 2020 as the market priced in those anticipated future earnings. Presently, its forward price-to-earnings (P/E) ratio is just over 8, which is quite low in comparison to the biotech industry's average of 30.21. So, even after its price spiked this year, it may not be overvalued based on its predicted earnings.

In 2021, we will get a much clearer picture of just what those earnings will look like. And, assuming everything goes well, the company will have at that point proven its vaccine-making capabilities, not to mention the merit of Matrix-M. For investors, proven science plus growing earnings will make the stock even more attractive.

https://www.fool.com/investing/2020/12/15/4-reasons-to-buy-novavax-in-2021-or-before/

Lilly lifts 2020 guidance, sets 2021 outlook ahead of consensus

 

• Eli Lilly (NYSE:LLY) sees full-year 2020 non-GAAP EPS of $7.45 - $7.65, up from previous guidance of $7.20 - $7.40, and well ahead of consensus $7.24.
• 2020 Revenue is now expected to be $24.2B to $24.7B from the previous $23.7B-$24.2B, and consensus of $23.95B.
• Non-GAAP gross margin is trimmed roughly 100 basis points to about 79%.
• Full-year 2021 non-GAAP EPS is seen at $7.75 - $8.40 vs. estimates for $8.08.
• Full-year 2021 revenue is expected at $26.5B - $28.0B vs. consensus $26.5B. The revenue estimate includes $1B-$2B from Covid-therapies.
• https://seekingalpha.com/news/3644332-lilly-lifts-2020-guidance-sets-2021-outlook-ahead-of-consensus-shares-rise-premarket

Centene to acquire PANTHERx

 

• Centene Corporation (NYSE:CNC) has signed a definitive agreement to acquire PANTHERx, one of the largest and fastest-growing specialty pharmacies in the United States specializing in orphan drugs and rare diseases.
• PANTHERx and its management team will continue to operate independently as part of Centene's Envolve Pharmacy Solutions, a total drug management program that includes integrated Pharmacy Benefit Manager services and specialty pharmacy solutions to millions of members throughout the United States.
• The transaction is expected to close by the end of 2020.
• Financial terms of the acquisition is undisclosed.
• https://seekingalpha.com/news/3644344-centene-to-acquire-pantherx

Athenex gains FDA approval of Klisyri in pre-cancerous skin lesion

 

• Athenex (NASDAQ:ATNX) jumps 10% premarket after FDA approved Klisyri (tirbanibulin) for the topical treatment of actinic keratosis (AK) on the face or scalp.
• Klisyri is the first FDA approved branded proprietary product for Athenex and will be launched in partnership with Almirall (OTC:LBTSF) in the U.S. during Q1 2021.
• In addition to the partnership with Almirall, Athenex has partnered with PharmaEssentia in Taiwan and with Xiangxue Pharmaceuticals in China, Hong Kong, and Macau for AK.
• Actinic keratosis is a pre-cancerous skin lesion. If left untreated, 10-15% of AK lesions will develop into skin cancers.
• https://seekingalpha.com/news/3644349-athenex-gains-10-on-fda-approval-of-klisyri-in-pre-cancerous-skin-lesion

Anavex's blarcamesine successful in mid-stage rett syndrome study

 

• Anavex Life Sciences soars (NASDAQ:AVXL) 50% in premarket on the heels of top-line results from a Phase 2 trial evaluating ANAVEX2-73 (blarcamesine) in adult female patients with Rett syndrome.
• Efficacy endpoints demonstrated statistically significant and clinically meaningful reductions in Rett syndrome symptoms and correlated with changes in biomarker.
• 66.7% of ANAVEX2-73 treated subjects showed a statistically significant improvement in drug exposure-dependent Rett Syndrome Behaviour score response as compared to 10% in placebo.
• 86.7% of patients in ANAVEX 2-73 arm showed a sustained improvement to treatment, as compared to 40% in placebo arm.
• Primary endpoint was safety. Adverse events were similar between Anavex2-73 and placebo, with no reported serious adverse events.
• The company is planning to meet with the FDA to discuss steps to approval.
• https://seekingalpha.com/news/3644357-anavexs-blarcamesine-successful-in-mid-stage-rett-syndrome-study