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Week Ahead (February 22- 26): Data Readouts, FDA Approval Decisions (CLNN, SRPT, DVAX, OTIC…)

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In the trading week ended Feb.19, nearly half a dozen stocks delivered over 50% returns.

Evolus Inc. (EOLS), with a gain of nearly 75%, was the top performer of the week, thanks to the settlement of all outstanding litigation with AbbVie and Medytox regarding the sale of Jeuveau, a neurotoxin injectable approved for the treatment of moderate to severe glabellar lines (wrinkles between the eyebrows).

Immunome Inc. (IMNM) returned over 60% gain for the week on news that it has isolated potent antibodies capable of neutralizing several SARS-CoV-2 variants, including the South African Variant (B.1.351), in pseudovirus testing.

Vaccinex Inc. (VCNX), Citius Pharmaceuticals Inc. (CTXR), NantKwest Inc. (NK) are the other stocks that gained more than 50% for the week.

Now, let's take a look at some of the pharma stocks that merit attention in the coming week.

1. Clene Inc. (CLNN)

Clene is a clinical-stage biopharmaceutical company developing unique therapeutics for neurodegenerative diseases. The company's lead asset is CNM-Au8, an orally delivered suspension of clean-surfaced, faceted gold nanocrystals.

CNM-Au8 is under a phase II study in patients with stable relapsing multiple sclerosis (MS) who have chronic optic neuropathy, dubbed VISIONARY-MS.

Preliminary results from the VISIONARY-MS trial, involving the first 34 participants, were reported last February. According to the interim data reported then, patients experienced gains in best-corrected low contrast letter acuity (BC-LCLA).

Expanded interim results, involving the first 44 enrolled participants, from the VISIONARY-MS phase II trial were reported last September. Data indicated a continued positive safety profile and the potential to improve MS visual and functional endpoints.

The company is slated to present updated blinded interim data from its VISIONARY-MS study on February 25.

CLNN closed Friday's (Feb.19, 2021) trading at $13.61, down 2.09%.

2. Sarepta Therapeutics Inc. (SRPT)

The FDA decision on Sarepta's Casimersen, proposed for the treatment of patients with Duchenne muscular dystrophy amenable to skipping exon 45, is expected on February 25.

There are already FDA-approved therapies for DMD caused by a mutation that would be amenable to skipping exon 51, which goes by the name Exondys 51, as well as for DMD caused by a mutation that would be impacted by skipping exon 53 under the name Vyondys 53.

If approved, Casimersen would be the third exon-skipping medicine for patients with Duchenne muscular dystrophy, and will be marketed under the brand name AMONDYS 45.

The global market size of Duchenne muscular dystrophy drugs is estimated to reach $4.11 billion by 2023, according to a new report by Grand View Research.

SRPT closed Friday's trading at $85.38, down 3.36%.

3. Dynavax Technologies Corporation (DVAX)

Dynavax is a commercial-stage biopharmaceutical company developing vaccines. The company's first commercial product, HEPLISAV-B, is approved in the U.S. for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older. This vaccine contains the adjuvant CpG 1018.

On Feb.19, the European Commission authorized Heplisav B, a 2 dose adult Hepatitis B adjuvanted vaccine.

Dynavax is also advancing CpG 1018 as a premier vaccine adjuvant through research collaborations and partnerships.

The company is scheduled to report fourth quarter and full year 2020 financial results on Thursday, February 25, 2021, after the U.S. financial markets close.

DVAX closed Friday's trading at $10.07, up 5.78%.

4. Johnson & Johnson (JNJ)

Johnson & Johnson's single-dose Covid-19 vaccine candidate is all set to be reviewed by an FDA panel on Feb.26.

In a phase III trial, dubbed ENSEMBLE, which included participants from different geographies and including those infected with an emerging viral variant, the Covid-19 vaccine candidate was 66% effective overall in preventing moderate to severe COVID-19, 28 days after vaccination.

If approved, Johnson & Johnson's single-dose Covid-19 vaccine would be the third vaccine to be approved for emergency use - the other two being Pfizer/BioNTech COVID-19 Vaccine and Moderna's COVID-19 Vaccine.

JNJ closed Friday's trading at $162.98, down 1.67%.

5. CorMedix Inc. (CRMD)

CorMedix is a biopharmaceutical company developing therapeutic products for the prevention and treatment of infectious and inflammatory diseases.

The FDA decision on the company's catheter lock solution to prevent infections associated with central venous catheters used by hemodialysis patients, named Defencath, is expected on February 28. This product, which received the CE Mark in 2013, is available in Europe and other territories under the brand name Neutrolin.

If approved, Defencath will be the first approved antimicrobial catheter lock solution in the U.S.

CRMD closed Friday's trading at $17.58, up 8.18%.

6. Athenex Inc. (ATNX)

Athenex is a global oncology-focused biopharmaceutical company.

The FDA decision on the company's Oral Paclitaxel in combination with Encequidar, proposed for the treatment of metastatic breast cancer, is expected on February 28.

Paclitaxel is a chemotherapy drug administered intravenously. Oral Paclitaxel is a reformulated version and is co-administered with Encequidar that enables the oral absorption of a wide range of effective anticancer drugs.

If approved, Oral Paclitaxel is expected to achieve blockbuster sales.

ATNX closed Friday's trading at $12.20, down 1.85%.

7. Otonomy Inc. (OTIC)

Otonomy is a biopharmaceutical company developing innovative therapeutics for neurotology.

The company's lead drug candidate is OTIVIDEX, under phase III study for the treatment of Ménière's disease, a disorder of the inner ear that is characterized by episodes of feeling like the world is spinning (vertigo), ringing in the ears (tinnitus), hearing loss, and a fullness in the ear.

The phase III trial of OTIVIDEX in Ménière's disease enrolled a total of 149 patients from the United States and Europe, exceeding the target of 142 patients. The results from this study are expected by the end of this month.

If all goes well, the company plans to submit a New Drug Application to the FDA in the third quarter of 2021.

OTIC closed Friday's trading at $5.39, up 0.75%.

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