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CLBS Firing On All Cylinders, SLDB Gets Ignited, SRPT Walks The Talk, SRRK Rocks

pharma daily 061218 lt

The following are some of today's top gainers in the pharma/biotech sector.

1. Caladrius Biosciences Inc. (CLBS)

Gained 67.34% to close Tuesday's (June 19) trading at $6.61.

News: The Company's late-stage CD34+ cell therapy program for the treatment of refractory angina has been granted regenerative medicine advanced therapy ("RMAT") designation by the FDA.

The RMAT designation affords regenerative therapies the advantages of expedited development and review of marketing applications as are available to drugs that receive breakthrough therapy designation, including increased meeting opportunities, early interactions to discuss potential surrogate or intermediate endpoints, shortened biologics license application ("BLA") review times and the potential of accelerated approval.

Caladrius acquired an exclusive worldwide license to the late-stage CD34+ program from Shire plc in March of this year.

2. Solid Biosciences Inc. (SLDB)

Gained 46.36% to close Tuesday's trading at $43.00. The stock touched a new high of $54.83 in intraday trading.

News: On June 18, 2018, the FDA lifted the clinical hold on IGNITE DMD, the Company's Phase I/II clinical trial of its lead product candidate SGT-001 for the treatment of Duchenne muscular dystrophy (DMD).

The IGNITE DMD was placed on clinical hold by the FDA on March 14, 2018, after 1 patient showed a decrease in platelet count followed by a reduction in red blood cell count and evidence of complement activation.

We had alerted our premium subscribers to this stock on May 14, 2018, (Report titled "Will it walk the talk?") when it was trading around $22.

3. Sarepta Therapeutics Inc. (SRPT)

Gained 36.76% to close Tuesday's trading at $143.93. The stock touched a high of $176.50 in intraday trading.

News: The Company presented positive preliminary results from the first three children dosed in its phase 1/2a gene therapy micro-dystrophin trial to treat patients with Duchenne muscular dystrophy.

According to the Company, biopsies performed at Day 90 showed robust micro-dystrophin expression in muscle measured by all methods in all three patients, and there was a significant decrease in levels of serum creatine kinase (CK), an enzyme biomarker strongly associated with muscle damage caused by Duchenne muscular dystrophy.

4. Neptune Technologies & Bioressources Inc. (NEPT)

Gained 31.84% to close Tuesday's trading at $3.23.

Neptune is a wellness products company.

News: The Company has entered into a multi-year agreement with Canopy Growth (WEED.TO) (CGC) to provide extracted cannabis products.

Jim Hamilton, President and CEO of Neptune said, "Today's agreement represents an important milestone in our cannabis growth strategy and validates our repositioning into larger global markets characterized by growth. Neptune has a history of producing high quality products for the natural health sector and is well positioned to apply and lever this experience to cannabis products."

5. Foundation Medicine Inc. (FMI)

Gained 28.46% to close Tuesday's trading at $136.75.

News: The Company is all set to be acquired by Roche (RHHBY.OB)

The outstanding shares of the Company's common stock not already owned by Roche and its affiliates will be acquired by Roche at a price of US$137.00 per share in cash. This corresponds to a total transaction value of US$2.4 billion on a fully diluted basis, and a total company value of US$5.3 billion on a fully diluted basis.

The transaction is expected to close in the second half of 2018.

6. Scholar Rock Holding Corp. (SRRK)

Gained 23.31% to close Tuesday's trading at $25.60.

News: No news


The Company's most advanced product candidate is SRK-015, being developed for the treatment of patients with Spinal Muscular Atrophy (SMA), which is under phase I testing.

Recent event:

The Company went public on the Nasdaq Global Select Market on May 24, 2018, offering its shares at a price of 14.00 each.

Clinical trials & Near-term Catalysts:

-- The ongoing Phase 1 clinical trial is evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of single- and multiple-ascending doses of intravenous SRK-015 in healthy adult volunteers.
-- Upon successful completion of the Phase 1 trial, the Company plans to initiate a Phase 2 proof-of-concept trial of SRK-015 in patients with later-onset Spinal Muscular Atrophy in the first quarter of 2019.

7. Celsion Corporation (CLSN)

Gained 19.42% to close Tuesday's trading at $3.32.

News: No news

Clinical Trials & Near-term Catalysts:

-- A pivotal phase III clinical study of ThermoDox in combination with radiofrequency ablation for primary liver cancer, dubbed OPTIMA, is underway, with enrollment expected to be completed in the third quarter of 2018.
-- Results from the first interim efficacy analysis of the OPTIMA study are expected to be available in the first half of 2019.
-- Report final progression-free survival data from a phase Ib clinical trial of GEN-1 in combination with neoadjuvant chemotherapy, the standard of care for patients newly diagnosed with ovarian cancer, dubbed OVATION I, by the end of the second quarter of 2018.
-- Initiate a Phase I/II randomized clinical trial of GEN-1 for the localized treatment of ovarian cancer, dubbed OVATION II, this month, and report clinical findings from the Phase I cohort of 12 patients of the OVATION II by the end of 2018.

8. Spero Therapeutics Inc. (SPRO)

Gained 18.53% to close Tuesday's trading at $13.50.

News: No news

Clinical Trials & Near-term Catalysts:

-- A pivotal phase III clinical trial of SPR994 for the treatment of complicated urinary tract infection (cUTI) is expected to be initiated around year-end 2018.
-- SPR741, which is being developed as a combination agent for the treatment of MDR infections, successfully completed phase I testing in healthy volunteers as recently as January of this year.
-- Also in the pipeline is SPR206, which is being developed for the treatment of serious Gram-negative infections, under preclinical testing.
-- Additional data from the IND-enabing studies of SPR720 are expected in the second half of 2018. SPR720 is an oral antibiotic designed for the treatment of an orphan disease, pulmonary non-tuberculous mycobacterial (NTM) infection.


Spero Therapeutics went public on the Nasdaq Global Select Market on November 2, 2017, offering its shares at a price of $14.00 each.

9. Evolus Inc. (EOLS)

Gained 15.57% to close Tuesday's trading at $32.66.

The Company is developing DWP-450 for the treatment of glabellar lines, also known as frown lines, in adult patients, a rival to Allergan's (AGN) Botox.

News: Evolus has expanded its management team with the appointment of Michael Mazen Jafar as Chief Marketing Officer. Jafar joins Evolus from Allergan where he most recently served as Vice President, Medical Aesthetics.

Recent events:

-- On May 16, 2018, the FDA rejected the Company's Biologics License Application for DWP-450 for the treatment of glabellar lines, also known as frown lines, in adult patients.

There were deficiencies in items related to Chemistry, Manufacturing, and Controls ("CMC") processes that led to the rejection. However, no deficiencies were related to clinical or non-clinical matters. Evolus expects to respond with a complete submission to FDA within 90 days.

-- The same day, i.e., on May 16, 2018, the Company also announced good news related to favorable completion of FDA's pre-approval inspection of Daewoong's manufacturing facility in South Korea which was purpose built for production of DWP-450.

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