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4 ‘Strong Buy’ Biotechs With Big 3Q19 Catalysts

Investing in biotech stocks can generate substantial returns. If data results meet key targets, or drug applications are accepted, share prices can soar. Unfortunately the reverse is also true. That means investors have to be particularly careful when it comes to biotech stocks. The following four stocks all show a Strong Buy Street consensus- based on ratings received over the last three months. They also boast significant upcoming catalysts this quarter- that could potentially send share prices soaring. Let’s take a closer look at each stock now:

1. Intercept Pharmaceuticals (ICPT)

Intercept Pharma is trying to help patients with progressive non-viral liver diseases. The company already has one drug on the market (for primary biliary cirrhosis), and recently released positive results from the Phase 3 REGENERATE trial in NASH Fibrosis.

Nash is a chronic condition in which the buildup of fat and inflammation in the liver may eventually lead to severe scarring called fibrosis. It is currently the second leading cause of liver transplant in the US- making it a very lucrative opportunity for drug companies.

Intercept has an early mover advantage here. The company plans to submit an NDA [new drug application] in 3Q19 and an MAA [marketing authorization application] in 4Q19. “Obeticholic Acid will likely be the first to market in NASH and is the only drug to have demonstrated a fibrosis benefit” cheers Needham analyst Alan Carr.

“We acknowledge certain potential safety and tolerability limitations, but nevertheless expect the drug to have an important role in NASH therapy over the next several years” says the analyst. Overall the stock has a ‘Strong Buy’ Street consensus, with 5 recent buy ratings vs just 1 hold rating. Meanwhile the average analyst price target of $148 indicates huge upside potential of 113%.

2. Rhythm Pharmaceuticals (RYTM)

Rhythm is developing treatments for rare genetic deficiencies that result in life-threatening metabolic disorders. The big news here is that Rhythm is expected to announce results in 3Q19 from two Phase 3 trials of setmelanotide in POMC and LEPR Deficiency. There are currently no approved drugs for these diseases- and no other drugs in development.

“We anticipate a positive outcome for both trials based on Phase 2 data demonstrating a profound and durable impact on appetite and weight” writes Carr. The analyst assumes US approval and launch in 4Q20 (EU 2021) and peak worldwide sales of around $265M in 2032.

“Considering recent weakness, we believe the stock is attractive ahead of Phase 3 POMC and LEPR Deficiency trial results. We believe there is even more room for upside for the stock as the company completes label expansion trials in 2020+” enthuses Carr.

Most notably label expansion Phase 3 trial in Bardet-Biedl/Alstrom Syndromes remains on track for results in 2H20. Success here adds another $485M in peak sales potential. “Additional patient populations under evaluation in a Phase 2 trial push peak sales above $1B” writes Carr. RYTM has four consecutive recent buy ratings from the Street, with an average price target of $40 (95% upside potential).

3. Moderna Inc (MRNA)

Moderna is hoping to create a new generation of transformative medicines for patients. The company’s approach is to use mRNA medicines to instruct a patient’s own cells to produce proteins that could prevent, treat, or cure disease. Encouragingly, all seven analysts covering MRNA rate the stock a buy- so no hold or sell ratings here.

“We expect Moderna to provide updates on Cytomegalovirus (CMV), Chikungunya, and Methylmalonic Acidemia (MMA) programs by YE19” writes the analyst.

While the commercial opportunity in Chikungunya is modest, he believes PK/PD data from the Phase 1 trial will provide valuable insight into the overall predictability of several other mRNA drugs in development at the company.

“The stock has fallen substantially from its peak in May 2019. We believe there is an opportunity for upside in 2H19 as the company announces data from the above CMV, Chikungunya, and MMA programs” Carr concludes. Indeed, the Street’s $30 average price target suggests share prices can double in the coming months.

4. Cara Therapeutics (CARA)

Cara Therapeutics has surged 30% in last the three months. In May the company announced positive results from the first of two Phase 3 trials of IV Korsuva in Chronic Kidney Disease (CKD) dialysis patients with pruritus. Pruritus refers to the severe itching of the skin, a common and distressing symptom for patients with chronic kidney disease.

Cara Therapeutics CEO Derek Chalmers noted at the time that the company was "particularly encouraged by the early [anti-itching] response with Korsuva injection." Now investors are keeping a close eye on results from the second trial (KALM-2) and from a Phase 2 trial of oral Korsuva in non-dialysis patients with CKD pruritus- both expected in 2H19.

“We anticipate a positive outcome for both trials” comments Carr, adding that the recent results point to a favorable outcome for the KALM-2 trial. “We believe the outcome is also a positive indicator for the oral Korsuva programs in CKD pruritus, Liver Disease pruritus, and Atopic Dermatitis, all of which have large commercial opportunities.”

Bottom line: “The stock is substantially undervalued.” All six analysts polled are bullish on CARA right now. Meanwhile the average analyst price target stands at $33 (30% upside potential).

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